Sun Pharmaceutical Industries Ltd.
FDA issued an amended warning letter to Sun Pharmaceutical Industries Ltd. (Halol, India) following a May 2022 inspection that found significant CGMP violations including inadequate media fills, poor aseptic technique, contaminated and damaged filling equipment, and insufficient contamination investigations. The violations affected sterile injectable products including medroxyprogesterone acetate injectable suspension and testosterone cypionate injection, with multiple voluntary recalls initiated. FDA placed the firm on Import Alert 66-40 and warned that continued non-compliance could result in refusal of admission of articles into the United States.
Required actions (4)
FDA placed your firm on Import Alert 66-40 on December 7, 2022.
After you receive this letter, respond to this office in writing within 15 working days.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Sun Pharmaceutical Industries Ltd, Halol, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
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