FDA WARNING_LETTER - Shilpa Medicare Limited - February 25, 2020

The FDA inspected Shilpa Medicare Limited, Unit-IV, from February 13-25, 2020, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate OOS results and complaints. * **OOS for Impurity:** An OOS result for impurity-(b)(4) in (b)(4) Tablets batch (b)(4) was inadequately investigated. The firm failed to identify a root cause, attributed an unknown chromatographic peak without support, and retested batches without including the original OOS batch. * **OOS for Assay:** Three batches of (b)(4) Injection showed OOS assay results. The firm concluded analytical error without sufficient scientific justification and released batches based on retest results, with inadequate CAPA details. * **Complaint Investigation - Sealing Defects:** An inadequate investigation for (b)(4) Injection batch (b)(4) where the enclosure separated from the vial, despite an unplanned deviation during manufacturing due to sealing defects. The batch was released without justification. * **Complaint Investigation - Foreign Particles:** Multiple complaints for foreign particles in (b)(4) Injection were inadequately evaluated.