Import Alert 85-02
-
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 85-02
Published Date: 02/14/2013
Type: DWPE
Import Alert Name:
*** "Detention Without Physical Examination of Condoms" ***
Reason for Alert:
The revision of this Import Alert dated 5/31/11 removes language calling for sampling at a 100% rate, and updates the contact information and terminology in the Import Alert. Changes are bracketed by asterisks (***).
This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.
Consumers rely on condoms for protection from HIV (AIDS) and other sexually transmitted diseases (STDs). Defective condoms present a potential hazard to health. Therefore, continuous monitoring of these devices is needed.
This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.
Consumers rely on condoms for protection from HIV (AIDS) and other sexually transmitted diseases (STDs). Defective condoms present a potential hazard to health. Therefore, continuous monitoring of these devices is needed.
Guidance:
Districts may detain, without physical examination, all shipments of condoms from the manufacturers/shippers listed on the *** the Red List of this import alert. ***
NOTE:
Because the presence of defects in condoms represents a potential hazard to health, only one (1) violative sample is needed to submit a recommendation for detention without physical examination to the Division of Import Operations & Policy (DIOP). DIOP has direct reference authority for detention without physical examination of condoms. Violative condoms are subject to RPM Chapter 9, Detention Without Physical Examination, subchapter "Recommendations Based on One Sample."
The following procedure has been developed to address those manufacturers/shippers who are found to repeatedly ship violative condoms to the U.S. (recidivist firms.)
Level 1 Detention (INDICATED BY (*) ON *** THE RED LIST) ***
When a district encounters a shipment of condoms which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to DIOP, HFC 170.
If the recommendation meets current guidance, the manufacturer/ shipper will be placed on *** the Red List ***, with a single asterisk (*), and subsequent condom shipments from that manufacturer/shipper may be detained without physical examination. This is referred to as "Level 1 detention." The importer may obtain admission of subsequently detained shipments of condoms by presenting evidence that the individual shipments are not adulterated, such as sample analyses performed by an independent testing laboratory, following the sampling plan and test method contained in FDA guidance.
In order for the responsible manufacturer's/shipper's name to be removed from *** the Red List ***, documentation should be provided with sufficient evidence that their condoms are not adulterated (for example, five consecutive non violative shipments analyzed as described in the preceding paragraph may be considered adequate evidence for manufacturers/shippers to be removed from Level 1 detention).
Level 2 Detention (Recidivist firms which are currently on Level 1 detention, or which have been removed from Level 1 detention)
If a manufacturer/shipper, while on Level 1 detention, has a sample analyzed by an independent testing laboratory found violative for defects, the district should notify DIOP and submit supporting documentation. DIOP will place the firm on Level 2 detention and identify the manufacturer/shipper on *** the Red List *** with two asterisks (**).
Similarly, if a manufacturer/shipper that has been removed from Level 1 detention has a sample analyzed by FDA and found violative for defects within 24 months from the date they were removed from Level 1 detention, the district should notify DIOP and submit supporting documentation. DIOP will verify the manufacturer/shipper was listed under Level 1 detention during the past 24 months and if confirmed
will place the manufacturer/shipper on Level 2 detention and identify the manufacturer/ shipper on *** the Red List *** with two asterisks (**).
DIOP will notify CDRH of this action. CDRH will notify the foreign firm in writing of FDA's concerns about potential deficiencies in the manufacturing practices and process controls which may be affecting the quality of the condoms shipped to the U.S. A copy of the Quality Systems Regulation will be provided with the letter for their information.
Once a manufacturer/shipper is placed on Level 2 detention, FDA may need greater assurance that the condoms are not adulterated before removing the manufacturer/shipper from detention without physical examination status. For example, 10 consecutive non violative shipments, analyzed by an independent testing laboratory for defects, may be considered adequate evidence that the manufacturer/shipper is shipping condoms to the U.S. which are not adulterated. Other types of evidence to remove the appearance of a violation will be evaluated by CDRH on a case by case basis.
Level 3 Detention (Recidivist firms which are currently on Level 2 detention, or which have been removed from Level 2 detention)
If a manufacturer/shipper, while on Level 2 detention, has another sample analyzed and found violative for defects by an independent testing laboratory, the district should notify DIOP and submit supporting documentation.
Similarly, if a manufacturer/shipper who was removed from Level 2 detention has another sample analyzed by FDA and has been found violative for defects within 24 months from the date they were removed from Level 1 detention, or from the date they were placed on Level 2 detention, DIOP will bring these instances to the attention of CDRH. DIOP will verify the manufacturer/shipper was listed under Level 2 detention during the past 24 months, and if confirmed will place the manufacturer/ shipper on *** the Red List *** with three asterisks (***).
Based on the failure of the manufacturer's/shipper's condoms to pass FDA analysis [Section 501(c)] after being listed on Level 2 detention, or having failed an independent testing laboratory's examination while under Level 2 detention, CDRH may then issue a Warning Letter to the firm.
Additionally, after reviewing the manufacturer/shipper's export and inspectional history, CDRH may elect to charge the firm for failure to conform with GMPs [Section 501(h)], based on the recurring Quality System Regulation deficiencies as revealed by the repeated failures of analyses. If CDRH determines a Warning Letter should issue to the foreign manufacturer/shipper with a 501(h) charge, DIOP will place the manufacturer/shipper on Level 3 detention *** the Red List ***.
Non violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers on *** the Red List ***. Manufacturers/ shippers will remain on Level 3 detention until evidence is provided to CDRH which demonstrates that the condoms are being manufactured in accordance with the Quality System Regulation (for example, an acceptable FDA inspection or a written certification from the manufacturer/shipper together with the results of an independent audit performed by a qualified third party).
Once a foreign manufacturer/shipper satisfactorily demonstrates that the apparent Quality System Regulation deviations have been corrected, the manufacturer/shipper will be removed from *** Level 2 detention and placed on Level 1 detention on the Red List for individual shipment analysis to confirm their condoms do not contain defects until they provide adequate evidence to be removed from Level 1 detention (see above).
*** Questions or issues involving import operations should be addressed to LCDR Chris Smith, Division of Import Operations & Policy, (301) 796-8967. ***
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-6600.
For questions concerning the Compliance Policy Guides (CPG), condom labeling, or other compliance policy questions, contact CDRH, Office of Compliance, Division of *** Enforcement A, 301-796-5500 or email the CDRH Import Safety Group at CDRH OC Import Mailbox (cdrhocimport@fda.hhs.gov).***
*** In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.
For guidance on removal from detention without physical examination, refer to the Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."
If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:
Food and Drug Administration
Division of Import Operations and Policy (HFC-170)
12420 Parklawn Drive,
ELEM - Room 3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov ***
SAMPLING:
Sampling should be conducted according to sampling plan in Compliance Policy Guide CPG 7124.21
NOTE:
Because the presence of defects in condoms represents a potential hazard to health, only one (1) violative sample is needed to submit a recommendation for detention without physical examination to the Division of Import Operations & Policy (DIOP). DIOP has direct reference authority for detention without physical examination of condoms. Violative condoms are subject to RPM Chapter 9, Detention Without Physical Examination, subchapter "Recommendations Based on One Sample."
The following procedure has been developed to address those manufacturers/shippers who are found to repeatedly ship violative condoms to the U.S. (recidivist firms.)
Level 1 Detention (INDICATED BY (*) ON *** THE RED LIST) ***
When a district encounters a shipment of condoms which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to DIOP, HFC 170.
If the recommendation meets current guidance, the manufacturer/ shipper will be placed on *** the Red List ***, with a single asterisk (*), and subsequent condom shipments from that manufacturer/shipper may be detained without physical examination. This is referred to as "Level 1 detention." The importer may obtain admission of subsequently detained shipments of condoms by presenting evidence that the individual shipments are not adulterated, such as sample analyses performed by an independent testing laboratory, following the sampling plan and test method contained in FDA guidance.
In order for the responsible manufacturer's/shipper's name to be removed from *** the Red List ***, documentation should be provided with sufficient evidence that their condoms are not adulterated (for example, five consecutive non violative shipments analyzed as described in the preceding paragraph may be considered adequate evidence for manufacturers/shippers to be removed from Level 1 detention).
Level 2 Detention (Recidivist firms which are currently on Level 1 detention, or which have been removed from Level 1 detention)
If a manufacturer/shipper, while on Level 1 detention, has a sample analyzed by an independent testing laboratory found violative for defects, the district should notify DIOP and submit supporting documentation. DIOP will place the firm on Level 2 detention and identify the manufacturer/shipper on *** the Red List *** with two asterisks (**).
Similarly, if a manufacturer/shipper that has been removed from Level 1 detention has a sample analyzed by FDA and found violative for defects within 24 months from the date they were removed from Level 1 detention, the district should notify DIOP and submit supporting documentation. DIOP will verify the manufacturer/shipper was listed under Level 1 detention during the past 24 months and if confirmed
will place the manufacturer/shipper on Level 2 detention and identify the manufacturer/ shipper on *** the Red List *** with two asterisks (**).
DIOP will notify CDRH of this action. CDRH will notify the foreign firm in writing of FDA's concerns about potential deficiencies in the manufacturing practices and process controls which may be affecting the quality of the condoms shipped to the U.S. A copy of the Quality Systems Regulation will be provided with the letter for their information.
Once a manufacturer/shipper is placed on Level 2 detention, FDA may need greater assurance that the condoms are not adulterated before removing the manufacturer/shipper from detention without physical examination status. For example, 10 consecutive non violative shipments, analyzed by an independent testing laboratory for defects, may be considered adequate evidence that the manufacturer/shipper is shipping condoms to the U.S. which are not adulterated. Other types of evidence to remove the appearance of a violation will be evaluated by CDRH on a case by case basis.
Level 3 Detention (Recidivist firms which are currently on Level 2 detention, or which have been removed from Level 2 detention)
If a manufacturer/shipper, while on Level 2 detention, has another sample analyzed and found violative for defects by an independent testing laboratory, the district should notify DIOP and submit supporting documentation.
Similarly, if a manufacturer/shipper who was removed from Level 2 detention has another sample analyzed by FDA and has been found violative for defects within 24 months from the date they were removed from Level 1 detention, or from the date they were placed on Level 2 detention, DIOP will bring these instances to the attention of CDRH. DIOP will verify the manufacturer/shipper was listed under Level 2 detention during the past 24 months, and if confirmed will place the manufacturer/ shipper on *** the Red List *** with three asterisks (***).
Based on the failure of the manufacturer's/shipper's condoms to pass FDA analysis [Section 501(c)] after being listed on Level 2 detention, or having failed an independent testing laboratory's examination while under Level 2 detention, CDRH may then issue a Warning Letter to the firm.
Additionally, after reviewing the manufacturer/shipper's export and inspectional history, CDRH may elect to charge the firm for failure to conform with GMPs [Section 501(h)], based on the recurring Quality System Regulation deficiencies as revealed by the repeated failures of analyses. If CDRH determines a Warning Letter should issue to the foreign manufacturer/shipper with a 501(h) charge, DIOP will place the manufacturer/shipper on Level 3 detention *** the Red List ***.
Non violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers on *** the Red List ***. Manufacturers/ shippers will remain on Level 3 detention until evidence is provided to CDRH which demonstrates that the condoms are being manufactured in accordance with the Quality System Regulation (for example, an acceptable FDA inspection or a written certification from the manufacturer/shipper together with the results of an independent audit performed by a qualified third party).
Once a foreign manufacturer/shipper satisfactorily demonstrates that the apparent Quality System Regulation deviations have been corrected, the manufacturer/shipper will be removed from *** Level 2 detention and placed on Level 1 detention on the Red List for individual shipment analysis to confirm their condoms do not contain defects until they provide adequate evidence to be removed from Level 1 detention (see above).
*** Questions or issues involving import operations should be addressed to LCDR Chris Smith, Division of Import Operations & Policy, (301) 796-8967. ***
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-6600.
For questions concerning the Compliance Policy Guides (CPG), condom labeling, or other compliance policy questions, contact CDRH, Office of Compliance, Division of *** Enforcement A, 301-796-5500 or email the CDRH Import Safety Group at CDRH OC Import Mailbox (cdrhocimport@fda.hhs.gov).***
*** In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.
For guidance on removal from detention without physical examination, refer to the Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."
If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:
Food and Drug Administration
Division of Import Operations and Policy (HFC-170)
12420 Parklawn Drive,
ELEM - Room 3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov ***
SAMPLING:
Sampling should be conducted according to sampling plan in Compliance Policy Guide CPG 7124.21
Product Description:
Condoms made from latex or synthetic material
NOTE:
This import alert does not apply to natural membrane condoms or to female condoms.
NOTE:
This import alert does not apply to natural membrane condoms or to female condoms.
Charge:
For lots that exceed an Acceptable Quality Level (AQL) of 0.4%:
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to contain defects/holes [Adulteration, section 501(c)]."
OASIS charge code - HOLES
If the condoms are labeled for the prevention of disease, also charge:
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that the labeling for disease prevention is false or misleading because the device contains defects/holes [Misbranding, section 502(a)]."
OASIS charge code - FALSE
When FDA has documented repeated violations, and the manufacturer/ shipper has been issued a Warning Letter and listed as Level 3 detention in *** the Red List *** of the import alert per the Recidivist Policy described below, future shipments may be detained charging the following:
"The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities and controls used for, the manufacture, packaging, storage, or installation of the device do not conform with Good Manufacturing Practices [Adulteration, section 501(h), Good Manufacturing Practices, section 520(f)]."
OASIS charge code - DEVICE GMP
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to contain defects/holes [Adulteration, section 501(c)]."
OASIS charge code - HOLES
If the condoms are labeled for the prevention of disease, also charge:
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that the labeling for disease prevention is false or misleading because the device contains defects/holes [Misbranding, section 502(a)]."
OASIS charge code - FALSE
When FDA has documented repeated violations, and the manufacturer/ shipper has been issued a Warning Letter and listed as Level 3 detention in *** the Red List *** of the import alert per the Recidivist Policy described below, future shipments may be detained charging the following:
"The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities and controls used for, the manufacture, packaging, storage, or installation of the device do not conform with Good Manufacturing Practices [Adulteration, section 501(h), Good Manufacturing Practices, section 520(f)]."
OASIS charge code - DEVICE GMP
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(85 H - - IS) Condom
Desc:Condom
(85 L - - TZ) Condom With Nonoxynol-9
Desc:Condom with Nonoxynol-9
(85 M - - OL) Condom, Non-Latex
Desc:Condom Non-Latex
BANGLADESH
Social Marketing Company
Date Published : 09/16/2009
House No 105 Road No 9A Dhanmondl , GPO Box 690 , Dhaka, BANGLADESH
85 H - - IS Condom
Date Published: 09/16/2009
Notes:firm is on Level 1 Detention Latex Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes:Latex Condoms
CHILE
SAGRA LABORATORY
Date Published : 09/16/2009
IGNACIO VALDIVIESO 2451 , SAN JOAQUIN, CHILE
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Latex Condoms; Firm si on Level 1 Detention
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes:Latex Condoms; Firm si on Level 1 Detention
CHINA
Guilin South Rubber (Group) Corp.
Date Published : 09/16/2009
No. 6, Wushan Road , Guilin, Guangxi, CHINA
85 H - - IS Condom
Date Published: 09/16/2009
Notes:All types of Condoms; Firm is on Level 1 Detention
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes:All types of Condoms; Firm is on Level 1 Detention
85 M - - OL Condom, Non-Latex
Date Published: 09/16/2009
Notes:All types of Condoms; Firm is on Level 1 Detention
Lestitch Co Ltd
Date Published : 08/31/2010
212 Zhaojiabang Road , Shanghai, CHINA
85 H - - IS Condom
Date Published: 08/31/2010
Desc:Latex Condoms
Notes:Level 1
Notes:Level 1
85 L - - TZ Condom With Nonoxynol-9
Date Published: 08/31/2010
Desc:Latex Condoms
Notes:Level 1
Notes:Level 1
85 M - - OL Condom, Non-Latex
Date Published: 08/31/2010
Desc:Latex Condoms
Notes:Level 1
Notes:Level 1
Pleasure Chest Group Company Ltd
Date Published : 09/13/2011
Add F6 No.777 North Chouzhou Rd , Zhejiang, CHINA
85 H - - IS Condom
Date Published: 09/13/2011
Desc:Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/13/2011
Desc:Condoms
85 M - - OL Condom, Non-Latex
Date Published: 09/13/2011
Desc:Condoms
SHANDONG DAHUI LATEX SCIENCE AND TECHNOLOGY CO., LTD
Date Published : 09/26/2011
TANGKOU INDUSTRY GARDEN , JINING, CHINA
85 H - - IS Condom
Date Published: 09/26/2011
Desc:Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/26/2011
Desc:Condoms
85 M - - OL Condom, Non-Latex
Date Published: 09/26/2011
Desc:Condoms
Tianjin Medicines & Health Products Imp. & Exp.Corp.
Date Published : 09/16/2009
6 Tang Shan Road , Tianjin, Tianjin CHINA
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Partners Brand Blue Spermicidally Lubricated w/Nonoxynol-9; extra
strength condom; Partners brankd Yellow Spermicidally Lubricated
w/Nonoxyol-9 condoms. Firm is on Level 1 Detention
GERMANY
Don Geschenkartikel-Neuheiten Dolores Obidos-Naumann
Date Published : 09/16/2009
Am Stadtbruch 14 , P O Box 1170 , Volkmarsen, GERMANY
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm is on Detention level one. All condoms
HONG KONG
Anna Mfgr LTD
Date Published : 09/16/2009
unknown , Hong Kong, HONG KONG
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm is on Detention level one. All condoms
HUNGARY
Industat Budapest KFT
Date Published : 09/16/2009
unknown , Budapest, HUNGARY
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm is on Detention level one. All condoms
INDIA
HEALTH CARE LATEX LTD.
Date Published : 09/16/2009
A-33/A SECTOR-8 , Noida (U.P.), INDIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm is on Detention level one. Latex Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes:Firm is on Detention level one. Latex Condoms
Hindustan Latex Limited
Date Published : 09/16/2009
Thiruvananthapuram , Kerala, INDIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm is on Detention level one. Condoms(Bull Dog Brand)
M/S Suruchi International
Date Published : 09/16/2009
207 Sector 7a Fardabad 121001 , Haryana, INDIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm is on Detention level one. Latex Condoms
85 L - - TZ Condom With Nonoxynol-9
Date Published: 09/16/2009
Notes:Firm is on Detention level one. Latex Condoms
85 M - - OL Condom, Non-Latex
Date Published: 09/16/2009
Notes:Firm is on Detention level one. Latex Condoms
KOREA, REPUBLIC OF (SOUTH)
Greenmate Corporation
Date Published : 09/16/2009
1443-15 Seocho-Dong , Seocho-Ku , Seoul, KOREA, REPUBLIC OF (SOUTH)
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm is on Detention level one. Latex Condoms
Orient Medical Supply Co Ltd (office)
Date Published : 09/16/2009
159 Sam Sung Dong , Room 3403 Korean World Trade Center , Seoul, KOREA, REPUBLIC OF (SOUTH)
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firms on detention level 1
Orient Medical Supply Co., Ltd.
Date Published : 09/16/2009
258-1, Youngwon-Ree, Sungnan- , Myun, Chunwon-Gun , Choongchung, Nam-Do KOREA, REPUBLIC OF (SOUTH)
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm on detention level 1
Shinheng Corporation
Date Published : 09/16/2009
Rm 1003 Daejun Bldg , 1318-4 Socho-Dong , Socho-Gu, Seoul KOREA, REPUBLIC OF (SOUTH)
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm on detention level1
Sol Medical Supply Co. Ltd.
Date Published : 09/16/2009
Unknown Street , Seoul, KOREA, REPUBLIC OF (SOUTH)
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm on detention level1
MALAYSIA
LS Rubber Sdn. Bhd.
Date Published : 09/16/2009
Plo 22 (Phase 1) , Senai Indust. Estate , Senai, MALAYSIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm on detention level 1; Condoms flavored
Richter Rubber Technology Sdn Bdh
Date Published : 09/16/2009
Plot 33, Kuala Ketil Indsutrial Estate , Kuala Ketil, Kedah, MALAYSIA
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm on detention level 1; latex condoms
THAILAND
Royal Industries Thailand Co Ltd
Date Published : 09/16/2009
218/5-6 Soi Rama 1 Road , Box 1347 , Bangkok, THAILAND
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm on detention level1
S L D International Co Ltd aka Ken Nona
Date Published : 09/16/2009
16 Asoke Rd Sukhumvit SOI 21 , Bangkok, Prakanong THAILAND
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firm on detention level1
UNITED KINGDOM
PHS Limited
Date Published : 09/16/2009
Claymore Tame Valley Industrial Estate , Tamworth, UNITED KINGDOM
85 H - - IS Condom
Date Published: 09/16/2009
Notes:Firms is on detention level 1; condoms with nonoxynol-9
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