FDA compliance of cosmetic OTC production sites
Certain cosmetic products are considered as OTC (Over The Counter Drugs) in the United States. Aprestigious luxury French brandcontacted CADUCEUM (specialist subsidiary of the ALTEN group) to bring its facilities into compliance withFDA(Food and Drug Administration) requirements, which is an essential prerequisite for the marketing of its key products.
With itspharmaceutical equipment qualification expertiseCADUCEUMrapidly formed a team of engineers toprepare the FDA inspection of several of the customer’s production platforms, by carrying out:
- Risk analyses (FMECA)
- Facility qualification
- Deviation management
After4 months of work, CADUCEUM’s engineers thus identified more than150 deviations, proposed corrective action plans, defined operational/performance qualification protocols, and scheduled the appropriate tests. This work, delivered on time, reinforced our customer’s credibility with the inspection authorities.