Fancystage Unipessoal, LDA – FDA Warning Letter, Aug 3, 2023

The FDA issued a Warning Letter to Fancystage Unipessoal, LDA, a manufacturer of OTC drug products, following a review of records submitted in response to a March 17, 2023, request. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include: 1. **Failure to conduct identity testing for components (21 CFR 211.84(d)(1)):** The firm did not adequately test each shipment of high-risk components, such as (b)(4) and (b)(4), for identity, specifically for potential (b)(4) or (b)(4) contamination using USP identification tests. This failure poses a significant safety risk due to the lethal poisoning incidents associated with these impurities. 2. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The Quality Unit (QU) failed to effectively exercise its responsibility and authority in approving or rejecting components in the Materials System. The FDA is concerned about potential lack of oversight in other CGMP operations like Production, Facilities & Equipment, Laboratory Controls, and Packaging & Labeling Systems.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist in meeting CGMP requirements, including a comprehensive six-system audit. The firm was placed on Import Alert 66-40 on May 8,