FDA 483 - Shilpa Pharma Lifesciences Limited - July 26, 2019

The FDA inspection of a pharmaceutical facility revealed multiple violations.

**Observation 1:** The facility failed to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, OOS investigations OOS/004/18/U-2 and OOS/005/18/U-2 for (b)(4) batches at the 36-month stability time point showed OOS failures in Related Substances testing, exceeding specification limits. No assignable root cause was identified. The investigations were deficient as a cross-functional team was not assembled to review relevant documents, including batch processing and cleaning records, and pre/post-batch records, as required by SOP #SOP/QA/GEN/003/12.

**Observation 2:** Equipment used in the manufacture of intermediates and APIs was not present at the facility. Specifically, (b)(4) of the (b)(4) pieces of equipment used to manufacture (b)(4) of the submission batches for API (b)(4) were discarded in February 2019 without documentation or assessment of replacement equipment.

**Observation 3:** Equipment and utensils were not cleaned and maintained at appropriate intervals to prevent contamination. * **A.** A 2016 clean hold time study for API manufacturing equipment was deficient and did not follow established protocols. The study was stopped due to exceeded results, but deviations, investigations, and