Fancystage Unipessoal, LDA Warning Letter Details

Summary

Fancystage Unipessoal, LDA, a Portuguese manufacturer of over-the-counter drug products for children, failed to conduct required identity testing on incoming components to verify they met safety specifications, particularly for high-risk materials subject to contamination. The company did not adequately test each shipment of component lots or perform the necessary USP limit tests to ensure components met relevant safety thresholds, resulting in adulterated drug products that did not conform to Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211. This compliance failure was identified through FDA's review of records submitted in response to a March 2023 information request.