FDA WARNING_LETTER - Strides Pharma Science Limited - February 05, 2019

On July 1, 2019, the FDA issued a Warning Letter to Strides Pharma Science Limited following an inspection from January 28 to February 5, 2019, at their Puducherry, India facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations included: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The Quality Unit (QU) lacked sufficient oversight. Investigators found discarded CGMP documents, including batch records for U.S. drug products, in a scrap yard, some dated just seven days before the inspection, without QU review. The firm's response was deemed inadequate for not assessing the full scope of discarded documents or the impact on distributed products. 2. **Failure to Thoroughly Investigate Discrepancies (21 CFR 211.192):** Out-of-specification (OOS) investigations were closed without adequate scientific justification. An example cited was an OOS for an API where an "old reagent" was identified as the root cause without reproducing the impurity or evaluating the original failing sample. The firm's response was inadequate, lacking supporting data for reserve