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# Sombra Cosmetics CGMP Violations
- URL: https://www.fdaweb.com/sombra-cosmetics-cgmp-violations/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158376

An FDA 7/15-7/26/2024 inspection at Sombra Cosmetics in Albuquerque, NM, found current good manufacturing practice (CGMP) regulation violations for finished drugs. A 12/18/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sombra-cosmetics-inc-692322-12182024?ref=fdaweb.com) says the specific violations were:

- failure to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of the firm component supplier’s test analyses at appropriate intervals;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.

FDA recommends that Sombra engage a qualified consultant to assist it in meeting CGMP requirements. It tells Sombra to correct any violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.