FDA WARNING_LETTER - Mahendra Chemicals - May 24, 2014

On July 13, 2015, the FDA issued a Warning Letter to Mahendra Chemicals following an inspection from May 19-24, 2014, which identified significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). These deviations render their APIs adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to record activities contemporaneously and destruction of original records:** Employees used "rough notes" for critical manufacturing data, then destroyed them after transcribing into batch records. Batch records were backdated, and lots were released before proper approvals, raising concerns about data integrity and reliability. 2. **Failure to prevent unauthorized data access/changes and ensure data completeness:** Laboratory systems lacked access controls, allowing deletion or alteration of raw data. There was no password functionality for GC, HPLC, or Karl Fischer Titrator instruments, and data acquisition software lacked active audit trails. 3. **Failure to train employees on operations and CGMP:** Multiple employees stated they hadn't received on-the-job training, and no training records were provided.

The FDA found the firm's June 16, 2014, response insufficient. The letter emphasizes that the quality system does not ensure data accuracy and integrity, and the quality unit lacks adequate authority. The FDA