L. Perrigo Company

FDA 483 - L. Perrigo Company

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An FDA inspection of Perrigo Company, PLC.'s Bio-pharmaceutical Analytical Facility in Allegan, MI, identified a significant data integrity issue. The firm failed to correctly convey test product slopes in a study report, leading to erroneous transcription and subsequent incorrect calculation of T/R ratios. This indicates a deficiency in data handling and quality control processes.

Company: L. Perrigo Company
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Operations
Person: Gajendiran Mahadevan (other)

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ID · b62725dc-47da-4c34-9a61-0654d6452bee