FDA WARNING_LETTER - Novacyl (Thailand) Ltd. - April 25, 2014

On February 27, 2015, the FDA issued a Warning Letter to Novacyl (Thailand), Ltd. following an inspection from April 21-25, 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 ensure reprocessing procedures consistently yield API meeting specifications:** The firm reprocessed rejected material, including out-of-specification (OOS) lots, as raw material without ensuring the reprocessed material met required assay and content specifications. One lot was reprocessed despite containing insoluble black specks due to poor cleaning, without adequate quality unit oversight or assurance of particle removal. 2. **Failure to maintain complete data from all testing and ensure data retention:** The firm did not retain complete raw electronic data for HPLC testing and method validation, including weights and calculations. An analyst selectively invalidated data without justification. 3. **Failure to prevent unauthorized access or changes to data and prevent data omission:** HPLC computer software lacked active audit trail functions and access controls, allowing deletion or alteration of raw data. Gas chromatograph (GC) software lacked password protection, granting uncontrolled access.

The FDA noted the firm's responses were insufficient, particularly regarding historical data review and systemic improvements