FDA WARNING_LETTER - Jost Chemical Co. - January 21, 2022

The FDA inspected Jost Chemical Co. from January 10-21, 2022, identifying significant deviations from CGMP for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Inadequate Quality Unit Investigations:** Failure to thoroughly investigate quality complaints and OOS results, such as a mold contamination in Potassium Sulfate, USP lot 36830004, and not expanding investigations to all potentially impacted lots. The firm also failed to adequately document investigations and evaluate the impact on products manufactured during the period of failure. 2. **Insufficient Equipment Cleaning Procedures:** Inadequate cleaning validation for non-dedicated manufacturing equipment, lacking documentation of campaign length, microbial contamination testing, and evaluation of remaining equipment. 3. **Unsound Microbial Test Procedures:** Microbial test procedures were inadequate, lacking growth promotion studies for in-house prepared media, and records did not identify analysts. 4. **Insufficient Computerized System Controls and Data Integrity Lapses:** Lack of unique passwords, controls to prevent data deletion, audit trail review procedures, and critical alarm procedures. The firm's quality system did not ensure data accuracy and integrity.

The FDA requires comprehensive corrective actions, including retrospective reviews of OOS investigations and laboratory data, independent assessments of investigation and laboratory systems, and remediation plans for cleaning validation and data integrity. A qualified consultant is strongly recommended. Failure to address these deviations promptly may result in regulatory action, including