Loading…
Multaler et Cie SAS, a French drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of YONKA PARIS SOLAR CARE SPF 50 UVA/UVB BROAD SPECTRUM FACE SUNSCREEN, an unapproved new drug marketed in the U.S. The company failed to adequately test incoming components for identity and conformity with specifications for purity, strength, and quality, and did not validate or establish the reliability of component supplier test analyses at appropriate intervals, as required under 21 CFR 211.84(d). These manufacturing and control deficiencies rendered the drug product adulterated, and the product was also misbranded, making its introduction into interstate commerce a violation of the Federal Food, Drug, and Cosmetic Act.