Sombra Cosmetics, Inc.

Warning LetterOpen

Mr. Alfredo Cortazar Owner and Chief Executive Officer (CEO) Sombra Cosmetics, Inc. 5951 Office Blvd NE Albuquerque , NM 87109-5822 United StatesFEI 1629960Issued Dec 18, 2024Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1629960.

Violations7

Issue DateDec 18, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Sombra Cosmetics, Inc.
Location: Mr. Alfredo Cortazar Owner and Chief Executive Officer (CEO) Sombra Cosmetics, Inc. 5951 Office Blvd NE Albuquerque , NM 87109-5822 United States
FEI Number: 1629960
Country: United States
Issue Date: December 18, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Sombra Cosmetics, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in its manufacturing of over-the-counter drug products including topical analgesic creams and hand sanitizers. The company failed to establish adequate written procedures for production and process control and did not adequately demonstrate that water used in manufacturing and equipment cleaning met United States Pharmacopeia specifications, including failures to conduct proper TOC and conductivity testing with multiple microbiological samples showing excessive contamination ("TNTC" - too numerous to count). The FDA found the company's August 2024 response to inspection findings inadequate, citing insufficient supporting documentation and lack of evidence demonstrating corrective actions to achieve CGMP compliance.

Sombra Cosmetics, Inc. FDA Warning Letter, December 18, 2024