Baja Fur S.A. de C.V. – FDA Warning Letter, Jul 12, 2019

The FDA issued a Warning Letter to Markwins Beauty Brands, Inc. following an inspection of their drug manufacturing operations at Baja Fur S.A. de C.V. in Tijuana, Mexico, from July 8-12, 2019. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigation of Discrepancies:** The firm failed to thoroughly investigate out-of-specification (OOS) microbiological contamination in multiple batches of OTC drug products, with results as high as (b)(4) CFU/g. Their response was inadequate as it lacked details on the contamination source and impact on distributed products. 2. **Insufficient Batch Production and Control Records:** Batch records lacked adequate production details, such as significant steps in filling operations and the personnel performing them. The firm's proposed updates were deemed insufficient for ensuring compliance. 3. **Inadequate Equipment Cleaning and Maintenance Procedures:** The firm failed to establish adequate written procedures and validate cleaning processes for shared equipment, raising concerns about cross-contamination. Their response did not assess the risk to product quality or marketed batches.

The FDA recommends engaging a qualified CGMP consultant to assist with compliance and perform a comprehensive audit. Failure to correct these violations may result in the FDA withholding approval of new drug applications and refusing admission of products manufactured