FDA EIR - Sovereign Pharmaceuticals, LLC - December 19, 2018

An FDA inspection of Sovereign Pharmaceuticals, LLC in Fort Worth, TX, conducted from December 11-19, 2018, uncovered six significant violations of current Good Manufacturing Practice (cGMP) regulations. The inspection, a routine cGMP assessment and complaint follow-up, focused on the contract manufacturer of human oral solid and liquid drug products.

Key issues included the firm's Quality Control Unit (QCU) lacking the necessary responsibility and authority to reject all drug products, particularly pilot/exhibit batches, due to the Research and Development department not consistently providing all laboratory data for QCU review. Written procedures for QCU responsibilities were also found to be inadequate regarding the final disposition of these batches. Furthermore, the company failed to thoroughly investigate unexplained discrepancies and batch failures, such as assay failures in bulk and finished products, and permitted unauthorized reprocessing of analytical data by analysts without QCU oversight.

A repeat observation from a previous inspection highlighted the firm's ongoing failure to adhere to its written stability testing program, with numerous drug products exceeding established timeframes for stability test interval completion. Additionally, Sovereign Pharmaceuticals could not provide the raw data and calculations essential for establishing cleaning validation parameters and acceptance limits. Cleaning validation procedures for a critical piece of equipment were also deemed deficient, lacking crucial visual aids like diagrams or photos of swab sampling locations.

In response, Sovereign Pharmaceuticals' management committed to submitting a formal written response to the FDA within 15 business days, outlining proposed corrective actions. The FDA stressed the firm's obligation to comply with all relevant regulations to avoid potential legal sanctions.