FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Puerto Rican Drugmaker Cited for Untimely Cleaning, Validations

Aug. 13, 2019
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The FDA hit Puerto Rico drugmaker Caribe Holdings with a Form 483 for not cleaning equipment and utensils at suitable intervals to prevent product contamination and for long delays in validating cleaning procedures.

The agency’s Feb. 21-March 6 inspection of the facility, which does business as PuraCap Caribe, revealed that some cleaning procedures were not validated on time, including validations for cleaning utensils, plastic bins and tablet press machines.

The firm also hadn’t completed a validation of the dirty and clean hold time for Simvastatin, a drug used for treating high cholesterol and triglyceride levels.

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