"Sterile Dosage Form Drugs"

FDA requires that domestic and foreign manufacturers assure the sterility of sterile finished drug products through process validation. We have openly stated that 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 CGMP and the product is deemed adulterated under 501(a)(2)(B). Likewise, if the product is being shipped without FDA approval as specified in Section 505, the product should not be admitted into the United States.

Districts may detain without physical examination all sterile finished drug products offered for entry unless the formulator/manufacturer has listed the product and FDA has inspected the firm and found them acceptable (or there is an acceptable inspection performed under a MOU in effect with a foreign government).

*** Districts should check FACTS to determine if the manufacturing facility has been inspected. If the foreign manufacturer is named in an approved NDA/ANDA, it has most likely been inspected by FDA. The Foreign Inspection Team/HFD-325 should be contacted to confirm that no acceptable inspection has been conducted before the entry is detained. ***

All Sterile Finished Drugs

"The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been manufactured, processed, or packed under insanitary conditions and it appears that the methods and controls used in its manufacture and control do not conform with current good manufacturing practice (CGMP) and thus it is adulterated within the meaning of Section 501(a)(2)(B) and/or subject to refusal of admission pursuant to Section 801(a)(3)."

OASIS charge code - DRUG GMPS