FDA WARNING_LETTER - The W.S. Badger Company, Inc. - September 14, 2021

The FDA issued Warning Letter 622318 to The W.S. Badger Company, Inc. on April 12, 2022, following an inspection from August 30 to September 14, 2021. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm lacked adequate process validation for multiple OTC drug products, including sunscreens, leading to out-of-specification (OOS) results. Cleaning validation was also inadequate. This is a repeat violation, with previous commitments unfulfilled. The FDA requires a detailed validation program summary, updated timelines for process performance qualification (PPQ) for all marketed products, and improvements to the cleaning validation program, including worst-case scenario considerations. 2. **Failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods (21 CFR 211.165(e)):** The firm used unvalidated analytical test methods, including for zinc oxide release and stability testing, performed by a third-party contract testing laboratory (CTL). This is a repeat violation. The FDA demands an independent assessment of all test methods, a status report and timelines for validation, and a comprehensive independent review of the entire