FDA 483 - Making Cosmetics Inc - March 05, 2021

Making Cosmetics Inc, a repacker/distributor in Redmond, WA, was cited for significant deficiencies during an FDA inspection. Observations included a lack of a written stability testing program for repacked APIs, unvalidated repackaging processes without adequate in-process controls, and insufficient cleaning procedures to prevent cross-contamination. Additionally, the firm failed to document actual weights of APIs in batch production records.