Syntec Pharma Corp – FDA Warning Letter, Oct 28, 2020

The FDA issued Warning Letter WL # 612765 to Syntec Pharma Corp. on July 6, 2021, following an inspection from October 7-28, 2020. The letter details significant CGMP deviations for active pharmaceutical ingredients (API), rendering their API adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to prevent mix-ups and loss of API identity/purity:** The firm repackaged, relabeled, and stored API, including highly potent and cytotoxic agents like Lomustine, in the same room using non-dedicated equipment without adequate procedures or documentation (e.g., batch records, equipment use logs). Inappropriate storage temperatures for Lomustine and HCG were observed, along with co-mingling of API with non-pharmaceutical items (weed killer, antifreeze, personal food). The firm's proposed corrective actions were deemed inadequate for failing to identify risks and provide a comprehensive CAPA plan. 2. **Inadequate cleaning procedures and validation:** The firm lacked written procedures for cleaning non-dedicated equipment used for potent API and failed to document usage and cleaning. An inappropriate cleaning agent was used, and cleaning validation studies were not conducted. The firm's response was inadequate as it did not provide evidence that cross-contamination had not occurred. 3. **Inadequate Quality