FDA 483 - L. Perrigo Company - October 22, 2019

L. Perrigo Company in Holland, MI, a drug manufacturer, was inspected by the FDA from October 7-22, 2019. The inspection revealed significant deficiencies in quality control, record-keeping, investigation processes, and facility maintenance. Issues included uncontrolled GMP documents, inadequate documentation of production procedures, insufficient discrepancy investigations, lack of secondary review for laboratory records, improper sample and raw material storage, and the use of chipped glassware.