FDA WARNING_LETTER - Fancystage Unipessoal, LDA - January 26, 2024

The FDA issued a Warning Letter to Fancystage Unipessoal, Lda, following an inspection from January 22-26, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's response to the FDA 483 was deemed inadequate due to insufficient supportive documentation and evidence of corrective actions.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming components for identity, purity, strength, and quality, relying on supplier Certificates of Analysis (COA) without validating their reliability. 2. **Inadequate production and process controls:** The firm lacked validated manufacturing processes and qualified equipment. The water system used in production and cleaning was not validated or adequately monitored for microbial limits. 3. **Insufficient laboratory controls:** The firm used cosmetic testing kits for microbial counts of OTC drug products, failed to validate non-compendial methods, did not perform growth promotion testing, and lacked qualified contract testing laboratories. 4. **Quality Control Unit (QCU) failures:** The QCU failed to ensure CGMP compliance, lacked adequate control over CGMP records (e.g., discarding batch records), and did not adequately review data accuracy and integrity.

Additionally, "THE HUMBLE CO. sodium fluoride 0.05% anticavity mouthwash FRESH MINT" was misbranded because its label