FDA Warning Letter issued due to Missing incoming Control Tests

In June 2024, the U.S. FDA issued a Warning Letter to Portuguese company Fancystage Unipessoal, LDA, following a January 2024 inspection. The letter highlights serious CGMP violations:

- Failure to test each component for identity and conformity with purity, strength, and quality specifications, and not validating supplier test reliability (21 CFR 211.84(d)(1) and 211.84(d)(2)).

- Lack of adequate procedures to ensure drug products meet their claimed identity, strength, quality, and purity (21 CFR 211.100(a)).

- Insufficient laboratory controls with inappropriate specifications and test procedures (21 CFR 211.160(b)).

- The quality control unit did not ensure compliance with CGMP and product specifications (21 CFR 211.22).

The FDA noted failures in incoming control tests and material verification, as outlined in ICH Q7 guidelines. An import alert was issued, and engaging a consultant for CGMP compliance is recommended. For more details, see the full Warning Letter for Fancystage Unipessoal, LDA.