IA #62-05 - 5/25/04, IMPORT ALERT #62-05, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF STERILE DOSAGE FORM DRUGS"
NOTE: This revision updates the guidance section. Changes are bracketed by
asterisks (***).
TYPE OF ALERT: Detention Without Physical Examination
NOTE: (This import alert represents the agency's current guidance to FDA field
personnel regarding the manufacturer or products 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).
PRODUCT: Sterile Finished Drugs
PRODUCT
CODE: 62 [] [] [] [] [] - Multiple
PROBLEM: Sterility
PAC FOR
COLLECTION: 56002/52002
COUNTRY: ALL
PAF: REG
OASIS CHARGE
CODE: DRUG GMP'S
MANUFACTURER/
SHIPPER: ALL
CHARGE: "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)."
RECOMMENDING
OFFICE: Center for Drug Evaluation and Research, Division of
Manufacturing and Product Quality, HFD-320.
REASON FOR
ALERT: 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.
GUIDANCE: 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, (301) 827-9073 should be contacted to confirm
that no acceptable inspection has been conducted before the
entry is detained. ***
PRIORITIZATION
GUIDANCE: Not applicable at this time
FOI: No purging is required
KEYWORDS: Drugs, Sterile Drugs, Process Validation, Sterility,
Finished Drugs, Sterile Dosage Forms, Dosage Form Drugs
PREPARED BY: Stella Notzon, DIOP, 301-443-6553
DATE LOADED
INTO FIARS: May 25, 2004
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