Import Alert 62-05

Import Alert # 62-05

Published Date: 11/02/2021

Type: DWPE

"Detention Without Physical Examination of Sterile Dosage Form Drugs From Manufacturers Not in Compliance with CGMPs"

Note: The revision of this Import Alert (IA) dated 11/2/2021 updates the name of the alert, the reason for alert, guidance, agency contacts, charge code language, product description, PAF, PAC and Products have been updated. Changes to the import alert are bracketed by asterisks (***).

***FDA requires that domestic and foreign manufacturers assure the sterility of finished drug products identified as sterile through process validation. Sterility cannot be assured through finished product testing alone; only sterility of that portion of a sample tested by current techniques can be assured and, unless the process being used has been demonstrated to be effective through validation, the manufacturer is not in compliance with current good manufacturing practice (CGMP) requirements, and the product is deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).***

***Divisions may detain without physical examination all sterile finished dosage form drug products offered for entry unless FDA has inspected the manufacturer and found it to be in compliance with CGMP requirements, that is, the final profile status of the inspection is acceptable, meaning there are no outstanding official action indicated (OAI) inspections and no compliance actions (or there is an acceptable inspection performed under a memorandum of understanding (MOU) in effect with a foreign government).***

*** Import Divisions should check the following import alerts prior to releasing the drug product to verify the manufacturer does not appear on the Red List.

• Import Alert 66-40, "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPS"
• Import Alert 66-79, "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"

In addition to registration, listing, and approval, verify that the foreign manufacturer has had a satisfactory CGMP inspection for sterile dosage form drugs, and the final profile status is acceptable (no outstanding OAI inspections and no compliance actions).

Detain if the declared manufacturer has not been inspected or the inspection was found unacceptable (there is an outstanding OAI inspection or compliance action has been taken). ***

***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 OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov.

Questions or issues involving drug products subject to this import alert should be addressed to CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov.***

***All Sterile Finished Dosage Form Drug Products***

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). [Adulteration, Section 501(a)(2)(B)]***

OASIS charge code: DRUG GMPS