AMPAC Fine Chemicals, LLC – FDA Warning Letter, Feb 19, 2010

On June 25, 2010, the FDA issued a Warning Letter to AMPAC Fine Chemicals, LLC, following an inspection from February 9-19, 2010, 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. The firm's March 12, 2010 response was deemed insufficient.

Key violations include: 1. **Failure to properly maintain buildings:** Dirt, blistering paint, rust, and oil droplets were found near manufacturing equipment. A January 2009 incident involved paint chips contaminating Temozolomide API, with subsequent corrective actions deemed ineffective. The firm's response lacked descriptions of controls to prevent contamination. 2. **Inadequate cleaning documentation and cross-contamination prevention:** A processing room used for Chlorambucil API was released for Temozolomide API without documented cleaning between batches. A room readiness audit form falsely affirmed the cleaning log was "complete and up-to-date." The firm's response did not explain how cleaning would be ensured. 3. **Failure to identify and quarantine returned APIs:** A drum of returned Temozolomide API was stored with accepted product without proper identification. The firm's response on new procedures for rejected batches did