Recently, The U.S. Food and Drug Administration (FDA) issued a warning letter to Intercos Europe SpA on August 15, 2024, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations in the production of over-the-counter (OTC) sunscreens. During an inspection of an Intercos manufacturing facility in Italy, the FDA identified several critical issues that compromise the safety, effectiveness, and quality of the sunscreens produced.
The FDA’s inspection revealed that Intercos failed to conduct proper testing of each component used in their products. The company did not verify the identity and conformity of components with the required specifications for purity, strength, and quality. Furthermore, Intercos did not validate or regularly confirm the reliability of their component supplier’s test analyses, as mandated by federal regulations (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Additionally, the FDA found that Intercos did not thoroughly investigate discrepancies or failures in batches or their components, regardless of whether those batches had been distributed. This lack of investigation violates another key regulatory requirement (21 CFR 211.192). Moreover, the FDA noted that laboratory records at Intercos were incomplete, lacking the necessary data to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
As a result of these findings, the FDA concluded that the quality system at Intercos does not sufficiently ensure the accuracy and integrity of data, which is crucial for maintaining the safety and effectiveness of the drugs they manufacture. The FDA has recommended that Intercos retain a qualified consultant to assist in addressing and remediating these issues.
