Sipra Labs Limited – FDA Warning Letter, Mar 1, 2014

The FDA inspected Sipra Labs Limited, a drug contract testing laboratory in Hyderabad, India, from February 24, 2014, to March 1, 2014, identifying significant CGMP violations for testing finished pharmaceuticals and APIs, rendering products adulterated. Previous inspections in 2009 and 2011 also found issues.

Key violations include: 1. **Failure to establish and document test method accuracy, sensitivity, specificity, and reproducibility (21 CFR §211.165(e))**: Ten analytical methods identified in the 2011 inspection remained unvalidated. The firm failed to follow its SOP for validation activities, specifically omitting robustness testing for a method, and approving a validation package without investigating precision. The firm's proposed corrective action of including a disclaimer was deemed inadequate, as it does not negate the CGMP requirement for validated methods. 2. **Failure to thoroughly investigate unexplained discrepancies or failures (21 CFR §211.192)**: The firm's procedures did not adequately address investigating anomalies or out-of-trend results. An analyst observed an anomaly with CHNOS analysis but there was no documentation of review or reporting to the client. The firm also lacked a validated practice for reusing HPLC/GC vials and stoppers, which was identified as a root cause for an Out-of-Specification assay.

Sipra Labs' responses dated March