Shilpa Medicare Limited — FDA 483 Findings

Scientific rational could not be provided for the following commercial product specifications: A.

The following issues were noted during the review ofthe analytical methods used in the finished product release of product for the U.S.

Your firm failed to thoroughly investigate any unexplained discrepancy or failure ofa batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

Scientific justification could not be provided for the following sample sizes: A.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods ofdisassembly and reassembling equipment as necessary to assure proper clean...

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.

The written stability program for drug products does not include reliable, meaningful, and specific test methods.

The following defects are not reflected in the visual inspection kits used to train the visual inspectors; ial/liquid, ™vials: Sealing (non-integral), broken/cracks, changes in liquid color, absence of stopper/ seal, less volume, more volume, color particle, coding, empty vial, molding defects, scratches, spot on spot onme seal.