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# Multiple Issues in Purolea Cosmetics Lab Inspection
- URL: https://www.fdaweb.com/multiple-issues-in-purolea-cosmetics-lab-inspection/
- Published: 2026-04-14T12:00:00.000Z
- Updated: 2026-09-14T13:37:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160978

A 10/28-10/30/2025 FDA inspection at the Purolea Cosmetics Lab drug manufacturing facility in Livonia, MI, found that the firm’s drug products are adulterated in that they have been prepared, packed, or held under insanitary conditions. A 4/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purolea-cosmetics-lab-722591-04022026?ref=fdaweb.com) also lists these current good manufacturing practice (CGMP) violations:

- failure to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms;
- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality; failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and failure to conduct microbiological testing before the use of a component with the potential for objectionable microbiological contamination in light of its intended use; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also cites the firm’s inappropriate use of artificial intelligence in pharmaceutical manufacturing, saying the company is legally required to review AI-generated documents to ensure they are accurate and comply with CGMP.

FDA acknowledges the company has ceased drug production and says the agency must be notified before it resumes production. Since there are company products within expiry in U.S. distribution, data are required to support whether the components and drug products meet established specifications such as identity, strength, quality, and purity, and that the drug products will remain within acceptable limits and retain their quality attributes through their labeled shelf-life until expiry, FDA says.

The agency reminds Purolea that it is responsible for the quality of the drugs it produces as a contractor, and also says that some of the company’s products may be regulated as cosmetics that must meet statutory and regulatory requirements.

Purolea was told to correct 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.