Import Alert 89-16

Import Alert # 89-16

Published Date: 12/11/2023

Type: DWPE

Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection

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.***

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 ***

***All Devices***

***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

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