FDA Issues Warning Letter to Intercos Europe

The US Food and Drug Administration (FDA) issued a warning letter to Intercos Europe SpA on August 15 regarding the manufacture of OTC sunscreens. FDA inspected an Intercos manufacturing facility in Italy and found “significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.”

Specifically, investigators found Intercos failed to:

• Test samples of each component for identity and conformity with all appropriate written specifications for purity, strength and quality. FDA said Intercos also failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

• Thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

• Ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

According to FDA, the Intercos quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA recommended retaining a qualified consultant to assist in remediation.