Import Alert 03-05
(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 # 03-05
Published Date: 04/04/2022
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Papad and Farfar Wafers From India"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 04/4/2022 updates the reason for alert, guidance section, agency contacts, product description and charge code language. Changes to the import alert are bracketed by asterisks (***).
From March through September 1991, 47 shipments of papad and farfar style products were offered for entry through various ports. Fourteen entries were detained without physical examination due to filth or pesticide contamination.
***26 shipments from 10 different manufacturers/packers were analyzed and found to be violative for insanitation due to the presence of insect, rodent and other filth violations.
In 2021, a total of 9 audit private laboratory samples of papad and farfar wafers were submitted as non-violative and 7 of those were found to be violative for Filth and refused entry.***
Papad wafers are parchment thin, brittle disks usually made from either wet-ground moong or urad-dal bean paste or tapioca or mashed potatoes and spices. The products can be sun-dried or heat processed.
From March through September 1991, 47 shipments of papad and farfar style products were offered for entry through various ports. Fourteen entries were detained without physical examination due to filth or pesticide contamination.
***26 shipments from 10 different manufacturers/packers were analyzed and found to be violative for insanitation due to the presence of insect, rodent and other filth violations.
In 2021, a total of 9 audit private laboratory samples of papad and farfar wafers were submitted as non-violative and 7 of those were found to be violative for Filth and refused entry.***
Papad wafers are parchment thin, brittle disks usually made from either wet-ground moong or urad-dal bean paste or tapioca or mashed potatoes and spices. The products can be sun-dried or heat processed.
Guidance:
***Divisions may detain, without physical examination, shipments of all varieties of papad and farfar wafers from India, except from those firms identified on the Green List of this alert.
Release of Articles Subject to Detention without Physical Examination Under this Import Alert:
In order to secure the release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence that the shipment does not contain filth at a level that is determined to be filthy within the meaning of Section 402(a)(3) of the Federal Food, Drug & Cosmetic Act. Such evidence could include private laboratory analysis of samples.
Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***
***Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):
In order to add a firm's product to the Green List of this Import Alert, 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. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).
For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov***
***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
Questions or issues on human food policy, or sample collection recommendations, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
***
Release of Articles Subject to Detention without Physical Examination Under this Import Alert:
In order to secure the release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence that the shipment does not contain filth at a level that is determined to be filthy within the meaning of Section 402(a)(3) of the Federal Food, Drug & Cosmetic Act. Such evidence could include private laboratory analysis of samples.
Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***
***Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):
In order to add a firm's product to the Green List of this Import Alert, 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. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).
For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov***
***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
Questions or issues on human food policy, or sample collection recommendations, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
***
Product Description:
Papad and farfar wafers, all varieties***(examples, including but not limited to: Fryum, Appalam, Papadum)***
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food [Adulterated, 402(a)(3)]***
OASIS charge code: FILTHY
OASIS charge code: FILTHY
Countries
INDIA
-
(03 Y - - 99) Other Bakery Products, N.E.C.
List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)
INDIA
MTR Foods Private Limited
Date Published : 09/10/2009
No. 80, Bommasandra Industrial Area , Hebbagodi, Anekal Taluk
, Bangalore,
Karnataka INDIA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 11/30/2009
Notes: Exempt - 6/29/2001
Valod Food Products
Date Published : 09/10/2009
Shedhi Road AT & Post valod
, Surat,
Gujarat INDIA
03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 11/30/2009
Notes: Exempt - 3/14/2002