FDA Issues Warning Letter to Intercos Europe

Cites violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (sunscreens).

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By: TOM BRANNA

Editor

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 specificat...

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