FDA Warning Letter - Missing incoming Control Tests

In June 2024, the U.S. FDA issued a Warning Letter to the Portuguese company "Fancystage Unipessoal, LDA" after having inspected its site in January 2024.

The significant violations of CGMP regulations for drug products, which are mentioned in the Warning Letter, are listed as follows:

• "Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2))."
• "Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a))."
• "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b))."
• "Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22)."

According to U.S. FDA Warning Letter, the firm failed to do proper incoming control tests to identify the goods. Testing and sampling of incoming goods are mandatory to verify the identity of the received materials and CGMP qualified suppliers are required. "ICH Q7 Good manufacturing practice for active pharmaceutical ingredients" guideline clearly describes these requirements in chapter 7.3 "Sampling and Testing of Incoming Production Materials".

The observed findings resulted in a long list of remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA has issued an import alert for this company. Engaging a consultant to ensure that the company will be CGMP compliant from now on is highly recommended in the Warning Letter.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Fancystage Unipessoal, LDA.