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# 3 CGMP Issues At Active Cosmetics Manufacturing
- URL: https://www.fdaweb.com/3-cgmp-issues-at-active-cosmetics-manufacturing/
- Published: 2026-05-05T12:00:00.000Z
- Updated: 2026-09-14T13:38:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161094

A 10/27-10/31/2025 FDA inspection at the Active Cosmetics Manufacturing drug manufacturing facility in Orlando, FL, found three significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/active-cosmetics-manufacturing-inc-722408-04222026?ref=fdaweb.com) says the specific violations were:

- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of the firm’s test methods; and
- failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals.

FDA recommended that Active Cosmetics retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It told the company 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.