Import Alert 99-32

"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION"

As part of FDA's 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 FDA's foreign inspection process, the Agency 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.

The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel provides an appearance that the firm¿s products are manufactured, processed, or packed under insanitary conditions.

The attachment to this alert identifies a firm(s) that has 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, for example compliance with FDA's Low-Acid Canned Food regulation, 21 C.F.R. Part 113. On the basis of a refusal from the firm(s), listed on the attachment, combined with other evidence, it appears that their articles were manufactured, processed, or packed under insanitary conditions for purposes of section 801(a)(1) of the act; therefore such articles are subject to refusal of admission into the US.

Districts may detain without physical examination all products from the firm(s)identified on the attachment 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 attachment 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 3109
Rockville, MD 20857

All

"The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions."

OASIS CHARGE CODE: REFUSE EI