Import Alert 89-16
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(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: 03/19/2013
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Products from Medical Device Firms
Refusing FDA Foreign Establishment Inspection
Refusing FDA Foreign Establishment Inspection
Reason for Alert:
As part of FDAs activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections of foreign manufacturers who produce FDA-regulated articles intended for sale in the US.
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 who offers devices for import into the United States refuses to permit or allow the 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 devices produced at such facility that are 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 devices manufactured at that facility are adulterated under section 501(h) of the act, as indicated in 21 CFR 820.1(d).
The attachment (Red List) to this alert identifies firms that have offered FDA-regulated articles for import into the United States and yet refused to allow the 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 US.
Recommending office: Office of Regional Operations (HFC-100)
Division of Foreign Field Investigations (HFC-130)
Problem: Inspection Refusal
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 who offers devices for import into the United States refuses to permit or allow the 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 devices produced at such facility that are 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 devices manufactured at that facility are adulterated under section 501(h) of the act, as indicated in 21 CFR 820.1(d).
The attachment (Red List) to this alert identifies firms that have offered FDA-regulated articles for import into the United States and yet refused to allow the 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 US.
Recommending office: Office of Regional Operations (HFC-100)
Division of Foreign Field Investigations (HFC-130)
Problem: Inspection Refusal
Guidance:
Districts may detain without physical examination all products from the firm(s) identified on the Red List to 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 under insanitary 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.
A manufacturer wishing to schedule an FDA inspection or to provide a copy of an inspection report conducted by a third party, should do so by submitting a request or documentation to the following address:
Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive
Elem Room 3109
Rockville, Maryland 20857
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 under insanitary 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.
A manufacturer wishing to schedule an FDA inspection or to provide a copy of an inspection report conducted by a third party, should do so by submitting a request or documentation to the following address:
Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive
Elem Room 3109
Rockville, Maryland 20857
Product Description:
All products
Charge:
For medical device producers/manufacturers: "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for the manufacture, packing, storage or installation do not conform to the requirements under section 520(f).
OASIS CHARGE CODE: DE IMP GMP
OASIS CHARGE CODE: DE IMP GMP
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