FDA WARNING_LETTER - Specialty Process Labs LLC - November 19, 2021

The FDA inspected Specialty Process Labs LLC's drug manufacturing facility in Phoenix, Arizona, from November 8-19, 2021, identifying significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to validate manufacturing processes:** Specifically, the thyroid, USP API process validation was inadequate, omitting several processing steps and failing a performance qualification for blending. The company's response was insufficient, lacking detailed protocols, timelines for prospective process performance qualification (PPQ) studies, and an assessment of the impact on currently marketed API. 2. **Inadequate laboratory testing:** The firm failed to retest API lots held for extended periods before blending, and final API was labeled with a re-evaluation date based on blending, not the oldest lot's manufacturing date. The response lacked timelines for corrective actions and stability studies. 3. **Insufficient computerized system controls:** Many systems lacked controls to prevent unauthorized access or data omission. The company's retrospective review plan was inadequate, lacking timelines and interim measures. 4. **Deficient microbiological test methods:** Microbiological test methods for thyroid, USP API were deficient, and the response lacked timelines, interim measures, and commitment to growth promotion testing. 5. **Quality unit failures:** The quality unit failed to perform routine functions, including vendor oversight and batch review. The response lacked timelines for corrective actions