Brief: Fagron: FDA Updates Warning Letter About Minnesota Facility

Fagron NV

29/06/2022 09:20

June 29 - The U.S. Food and Drug Administration (FDA):
    * PUBLISHED ON TUESDAY UPDATE OF WARNING LETTER ABOUT
MINNESOTA
DRUG MANUFACTURING FACILITY OF FAGRON  FAGRO.BR 
    * WARNING LETTER SUMMARIZES SIGNIFICANT DEVIATIONS FROM
CURRENT
GOOD MANUFACTURING PRACTICE (CGMP) FOR ACTIVE PHARMACEUTICAL
INGREDIENTS (API)
    * METHODS, FACILITIES, OR CONTROLS FOR MANUFACTURING,
PROCESSING,
PACKING, OR HOLDING DO NOT CONFORM TO CGMP, YOUR API ARE
ADULTERATED WITHIN THE MEANING OF SECTION 501(A)(2)(B) OF THE
FEDERAL FOOD, DRUG, AND COSMETIC ACT (FD&C ACT), 21 U.S.C.
351(A)(2)(B)
    * DURING FDA INSPECTION, INVESTIGATORS OBSERVED SPECIFIC
DEVIATIONS
    * FAILURE TO PERFORM REPACKAGING OF API UNDER APPROPRIATE
CGMP TO
AVOID POTENTIAL CROSS-CONTAMINATION
    * FAILURE TO ADEQUATELY INVESTIGATE AND DOCUMENT
OUT-OF-SPECIFICATION RESULTS AND IMPLEMENT APPROPRIATE
CORRECTIVE ACTIONS
    * FAILURE OF YOUR QUALITY UNIT TO EXERCISE ITS
RESPONSIBILITY TO
ENSURE THE API MANUFACTURED AT THE FACILITY ARE IN COMPLIANCE
WITH CGMP
    * FAILURE TO PROMPTLY CORRECT THESE DEVIATIONS MAY RESULT IN
LEGAL
ACTION WITHOUT FURTHER NOTICE INCLUDING, WITHOUT LIMITATION,
SEIZURE AND INJUNCTION
    * UNRESOLVED DEVIATIONS IN THIS WARNING LETTER MAY ALSO
PREVENT
OTHER FEDERAL AGENCIES FROM AWARDING CONTRACTS
    * FAILURE TO ADDRESS DEVIATIONS MAY ALSO CAUSE FDA TO
WITHHOLD
ISSUANCE OF EXPORT CERTIFICATES
    * FDA MAY WITHHOLD APPROVAL OF ANY NEW APPLICATIONS OR
SUPPLEMENTS
LISTING YOUR FIRM AS A DRUG MANUFACTURER UNTIL ANY DEVIATIONS
ARE COMPLETELY ADDRESSED AND WE CONFIRM YOUR COMPLIANCE WITH
CGMP

 Source text: https://bit.ly/3bEqFB7
 Further company coverage:  FAGRO.BR  

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