FDA WARNING_LETTER - Pharmasol Corporation - August 20, 2018

The FDA issued a Warning Letter to Pharmasol Corporation following inspections of their South Easton, MA (July 23 - August 20, 2018) and Stoughton, MA (August 2 - August 20, 2018) drug manufacturing facilities. The inspections revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated.

At the South Easton facility, violations included: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm failed to investigate out-of-specification (OOS) stability testing results, specifically recurring container-closure leakage in drug products, even after changing the container-closure system. Four leakage complaints were classified as "unconfirmed." The firm's proposed corrective actions were deemed inadequate as they did not identify a root cause. 2. **Inadequate Quality Control Unit (21 CFR 211.22(a) and (d)):** The Quality Unit (QU) failed to review, approve, and close investigations (e.g., laboratory, complaint, deviations) and CAPAs within reasonable timeframes, with over 40 deviations open past due dates, some for over a year. The QU also did not follow procedures for out-of-limit environmental monitoring results or test for yeasts and