FDA 483 - Delicate Cosmetics, Inc. - June 27, 2025

An FDA inspection of Delicate Cosmetics, Inc. in Sun Valley, CA, a pharmaceutical contract manufacturer, revealed significant deficiencies in their quality system. Observations included inaccurate batch production records due to inadequate change control, a failure to document in-process sampling for microbiological and assay testing, and the release of drug product without evidence of satisfactory conformance to final specifications. These issues indicate a lack of robust control over manufacturing and release processes.