(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 # 89-16
Published Date: 12/11/2023
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 10/27/2021 updates the reason for alert section, guidance section including agency contacts, product description, charge section and PAC. Changes to the import alert are bracketed by asterisks (***).
As part of FDAs activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections of foreign manufacturers that produce FDA-regulated articles intended for sale in the United States.
As part of this inspection process, FDA may contact the foreign manufacturer and schedule the establishment inspection; however, there is no such requirement to do so. Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin.
If a manufacturer that offers devices for import into the United States refuses to permit or allow the initiation or completion of an FDA inspection of the foreign facility for the purpose of determining compliance with 21 CFR 820, it shall appear for purposes of section 801(a) of the act, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any device produced at such facility that is offered for import into the United States do not conform to the requirements of section 520(f) of the act and 21 CFR 820 and that the device(s) manufactured at that facility are adulterated under section 501(h) of the act, as indicated in 21 CFR 820.1(d).
*** The Red List to this alert identifies firms that have offered FDA-regulated articles for import into the United States but, however, have refused to allow the initiation or completion of an FDA inspection of its foreign facility for the purpose of determining facility conditions and compliance with applicable laws and regulations.
Therefore, articles from these firms are subject to refusal of admission into the United States.***
Guidance:
Divisions may detain without physical examination all products from the firm(s) identified on the Red List of this import alert.
NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results to be insufficient to overcome the appearance of the product having been prepared, packed, or held in unsubstantiated conditions. In addition, the appearance of a violation per Section 801(a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.
Products imported from the firm(s) listed on the Red List to this import alert should remain subject to detention without physical examination until an FDA inspection is completed. Firms may provide copies of inspection reports for inspections performed by third parties only to assist FDA in prioritizing inspection requests.
*** To remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the condition (refusal of FDA inspection) 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 (i.e., the Act). For guidance on removal from detention without physical examination, refer to FDA's 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, submit a request (which may include copies of inspection reports for inspections performed by third parties) to schedule an FDA inspection to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM 3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to the Division of Import Operations (DIO) at 301-796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues on device policy, or any other questions, should be addressed to CDRH at cdrhimport@fda.hhs.gov ***
Product Description:
***All Devices***
Charge:
***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 or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).***
OASIS CHARGE CODE: DE IMP GMP
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
Intop Tech Co Ltd 2005 Dragon Bearl
Date Published : 05/22/2013
Zhonghuanguangchang No , 2123 Pudonga Ve
, Shanghai,
Shanghai CHINA
73 - - - -- Anesthesiology
Date Published: 05/22/2013
74 - - - -- Cardiovascular
Date Published: 05/22/2013
76 - - - -- Dental
Date Published: 05/22/2013
77 - - - -- Ear,Nose And Throat
Date Published: 05/22/2013
78 - - - -- Gastroenterological & Urological
Date Published: 05/22/2013
79 - - - -- General & Plastic Surgery
Date Published: 05/22/2013
80 - - - -- General Hospital/Personal Use
Date Published: 05/22/2013
84 - - - -- Neurological
Date Published: 05/22/2013
85 - - - -- Obstetrical & Gynecological
Date Published: 05/22/2013
86 - - - -- Ophthalmic
Date Published: 05/22/2013
87 - - - -- Orthopedic
Date Published: 05/22/2013
89 - - - -- Physical Medicine
Date Published: 05/22/2013
90 - - - -- Radiological
Date Published: 05/22/2013
NINGBO BELLAVIE ELECTRIC APPLIANCE CO.,LTD
Date Published : 12/11/2023
Gaoqiao Town , Qiyang Village; Haishu District
, Ningbo,
Zhejiang CHINA
73 - - - -- Anesthesiology
Date Published: 12/11/2023
Notes: All Devices
74 - - - -- Cardiovascular
Date Published: 12/11/2023
Notes: All Devices
76 - - - -- Dental
Date Published: 12/11/2023
Notes: All Devices
77 - - - -- Ear,Nose And Throat
Date Published: 12/11/2023
Notes: All Devices
78 - - - -- Gastroenterological & Urological
Date Published: 12/11/2023
Notes: All Devices
79 - - - -- General & Plastic Surgery
Date Published: 12/11/2023
Notes: All Devices
80 - - - -- General Hospital/Personal Use
Date Published: 12/11/2023
Notes: All Devices
84 - - - -- Neurological
Date Published: 12/11/2023
Notes: All Devices
85 - - - -- Obstetrical & Gynecological
Date Published: 12/11/2023
Notes: All Devices
86 - - - -- Ophthalmic
Date Published: 12/11/2023
Notes: All Devices
87 - - - -- Orthopedic
Date Published: 12/11/2023
Notes: All Devices
89 - - - -- Physical Medicine
Date Published: 12/11/2023
Notes: All Devices
90 - - - -- Radiological
Date Published: 12/11/2023
Notes: All Devices
96 - - - -- Radio Frequency Emitting Products
Date Published: 12/11/2023
Desc: All Devices
Ningbo Bella Vie Co., Ltd.
Date Published : 12/11/2023
Minlecun , Gaoqiaozhen Yinzhou
, Ningbo,
Zhejiang CHINA
73 - - - -- Anesthesiology
Date Published: 12/11/2023
Notes: All Devices
74 - - - -- Cardiovascular
Date Published: 12/11/2023
Notes: All Devices
76 - - - -- Dental
Date Published: 12/11/2023
Notes: All Devices
77 - - - -- Ear,Nose And Throat
Date Published: 12/11/2023
Notes: All Devices
78 - - - -- Gastroenterological & Urological
Date Published: 12/11/2023
Notes: All Devices
79 - - - -- General & Plastic Surgery
Date Published: 12/11/2023
Notes: All Devices
80 - - - -- General Hospital/Personal Use
Date Published: 12/11/2023
Notes: All Devices
84 - - - -- Neurological
Date Published: 12/11/2023
Notes: All Devices
85 - - - -- Obstetrical & Gynecological
Date Published: 12/11/2023
Notes: All Devices
86 - - - -- Ophthalmic
Date Published: 12/11/2023
Notes: All Devices
87 - - - -- Orthopedic
Date Published: 12/11/2023
Notes: All Devices
89 - - - -- Physical Medicine
Date Published: 12/11/2023
Notes: All Devices
90 - - - -- Radiological
Date Published: 12/11/2023
Notes: All Devices
96 - - - -- Radio Frequency Emitting Products
Date Published: 12/11/2023
Desc: All Devices
Shanghai Realov Electronic Technology Co Ltd
Date Published : 11/02/2015
Floor 3 , 799/26 Middle Jia Song Road
, Shanghai,
Shanghai CHINA
73 - - - -- Anesthesiology
Date Published: 11/02/2015
Notes: All medical devices
74 - - - -- Cardiovascular
Date Published: 11/02/2015
Notes: All medical devices
76 - - - -- Dental
Date Published: 11/02/2015
Notes: All medical devices
77 - - - -- Ear,Nose And Throat
Date Published: 11/02/2015
Notes: All medical devices
78 - - - -- Gastroenterological & Urological
Date Published: 11/02/2015
Notes: All medical devices
79 - - - -- General & Plastic Surgery
Date Published: 11/02/2015
Notes: All medical devices
80 - - - -- General Hospital/Personal Use
Date Published: 11/02/2015
Notes: All medical devices
84 - - - -- Neurological
Date Published: 11/02/2015
Notes: All medical devices
85 - - - -- Obstetrical & Gynecological
Date Published: 11/02/2015
Notes: All medical devices
86 - - - -- Ophthalmic
Date Published: 11/02/2015
Notes: All medical devices
87 - - - -- Orthopedic
Date Published: 11/02/2015
Notes: All medical devices
89 - - - -- Physical Medicine
Date Published: 11/02/2015
Notes: All medical devices
90 - - - -- Radiological
Date Published: 11/02/2015
Notes: All medical devices
INDIA
Sewa Medicals Ltd
Date Published : 05/28/2014
Gut No. 229-232, Alandi Markal Road , Village Markal Taluka Khed, Taluka:Khed
, Pune,
Maharashtra INDIA
73 - - - -- Anesthesiology
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
74 - - - -- Cardiovascular
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
76 - - - -- Dental
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
77 - - - -- Ear,Nose And Throat
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
78 - - - -- Gastroenterological & Urological
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
79 - - - -- General & Plastic Surgery
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
80 - - - -- General Hospital/Personal Use
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
84 - - - -- Neurological
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
85 - - - -- Obstetrical & Gynecological
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
86 - - - -- Ophthalmic
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
87 - - - -- Orthopedic
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
89 - - - -- Physical Medicine
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
90 - - - -- Radiological
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
94 - - - -- Ionizing Non-Medical Devices and Components
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
95 - - - -- Light Emitting Non-Device Products
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
96 - - - -- Radio Frequency Emitting Products
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
97 - - - -- Sound Emitting Products
Date Published: 05/28/2014
Notes: Manufacturer (medical devices)
KOREA (THE REPUBLIC OF)
Dongkuk Trading Company, Ltd.
Date Published : 03/15/2021
Kangnam-ku , Dongkuk Bldg. 556-27, Sinsa-Dong
, Seoul,
KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 03/15/2021
Notes: All Devices
74 - - - -- Cardiovascular
Date Published: 03/15/2021
Notes: All Devices
76 - - - -- Dental
Date Published: 03/15/2021
Notes: All Devices
77 - - - -- Ear,Nose And Throat
Date Published: 03/15/2021
Notes: All Devices
78 - - - -- Gastroenterological & Urological
Date Published: 03/15/2021
Notes: All Devices
79 - - - -- General & Plastic Surgery
Date Published: 03/15/2021
Notes: All Devices
80 - - - -- General Hospital/Personal Use
Date Published: 03/15/2021
Notes: All Devices
84 - - - -- Neurological
Date Published: 03/15/2021
Notes: All Devices
85 - - - -- Obstetrical & Gynecological
Date Published: 03/15/2021
Notes: All Devices
86 - - - -- Ophthalmic
Date Published: 03/15/2021
Notes: All Devices
87 - - - -- Orthopedic
Date Published: 03/15/2021
Notes: All Devices
89 - - - -- Physical Medicine
Date Published: 03/15/2021
Notes: All Devices
90 - - - -- Radiological
Date Published: 03/15/2021
Notes: All Devices
TAIWAN
Morris Engineering Works Ltd.
Date Published : 09/16/2014
Kuan Tien Ind. District , No. 43 Kung Yeh Road
, Tainan City,
TAIWAN
73 - - - -- Anesthesiology
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
74 - - - -- Cardiovascular
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
76 - - - -- Dental
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
79 - - - -- General & Plastic Surgery
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
84 - - - -- Neurological
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
86 - - - -- Ophthalmic
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
87 - - - -- Orthopedic
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
89 - - - -- Physical Medicine
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
90 - - - -- Radiological
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
94 - - - -- Ionizing Non-Medical Devices and Components
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
95 - - - -- Light Emitting Non-Device Products
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
96 - - - -- Radio Frequency Emitting Products
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)
97 - - - -- Sound Emitting Products
Date Published: 09/16/2014
Notes: Manufacturer (medical devices)