FDA WARNING_LETTER - Smruthi Organics Limited - October 18, 2013

This FDA Warning Letter, dated March 6, 2014, was issued to Smruthi Organics Ltd following an inspection from October 15-18, 2013, at their Solapur, India facility. The inspection identified significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated.

Key violations include: 1. **Failure to maintain complete and accurate laboratory test data:** This involved missing written explanations for HPLC audit trail deletions, lack of electronic raw data retention instructions, absence of integration parameters for HPLC analyses, incomplete raw data for test method validation/verification (specifically for residual solvents), performing unjustified "trial injections" before official tests, and unauthentic calibration/media preparation records where signees were not present. 2. **Failure to maintain and make available production and control records:** The firm was found to have blended out-of-specification (OOS) API batches, and relevant records were initially stated as destroyed, then later claimed to be misplaced. 3. **Inadequate investigations of critical deviations:** Investigations into particulate matter complaints in API batches were incomplete and inconclusive.

Additional deficiencies noted include a duplicate logbook with altered pages, inability to recover HPLC integration parameters for retained samples, and a general lack of controls to prevent data manipulation.

The FDA requires a comprehensive corrective action plan addressing these issues, including a retrospective review of all affected data, re-