# FDA WARNING_LETTER - Baja Fur S.A. de C.V. - July 12, 2019

Source: https://www.keypedia.com/records/warning_letter/baja-fur-sa-de-cv/f2fe14c4-8707-4089-bf09-cf18a33646d2

> FDA WARNING_LETTER for Baja Fur S.A. de C.V. on July 12, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Baja Fur S.A. de C.V.
- Inspection Date: 2019-07-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/baja-fur-sa-de-cv/f4eb618b-20c0-4f08-8986-b6294e494546

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c