FDA WARNING_LETTER - Stason Pharmaceuticals, Inc. - October 25, 2019

On July 8, 2020, the FDA issued a Warning Letter to Stason Pharmaceuticals, Inc. following an inspection from October 3-25, 2019, at their Irvine, CA facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm failed to determine a root cause for out-of-specification (OOS) dissolution results for temozolomide capsules, even after a relaxed specification was approved and a lot was recalled. Their investigation into dissolution variability was inadequate, lacking a clear root cause and effective CAPA. Interim measures for cleaning issues post-methotrexate tablet manufacture were also insufficient. The FDA requested comprehensive dissolution testing results, stability program details, and shipped lot numbers.

2. **Inadequate controls over computer systems (21 CFR 211.68(b)):** The firm lacked sufficient controls to ensure electronic test data integrity. Specifically, the spectrophotometer used for product release and stability testing allowed data files to be deleted without quality unit knowledge. The firm's response was inadequate as it failed to include a comprehensive review of all laboratory instruments for appropriate user roles and lacked a