FDA compliance of cosmetic OTC production sites - ALTEN Group

FDA compliance of cosmetic OTC production sites

Certain cosmetic products are considered as OTC (Over The Counter Drugs) in the United States. A prestigious luxury French brand contacted CADUCEUM (specialist subsidiary of the ALTEN group) to bring its facilities into compliance with FDA (Food and Drug Administration) requirements, which is an essential prerequisite for the marketing of its key products.

With its pharmaceutical equipment qualification expertise CADUCEUM rapidly formed a team of engineers to prepare the FDA inspection of several of the customer’s production platforms, by carrying out:

  • Risk analyses (FMECA)
  • Facility qualification
  • Deviation management

After 4 months of work, CADUCEUM’s engineers thus identified more than 150 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.