L. Perrigo Company

FDA 483 - L. Perrigo Company

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An FDA inspection of Perrigo Company, PLC, a bio-pharmaceutical analytical facility in Allegan, MI, identified a significant data integrity issue. The firm incorrectly transcribed test product slopes in a study report. This transcription error resulted in the erroneous calculation and reporting of T/R ratios during in vitro release testing.

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 · 2d02d8e2-e339-4962-8b73-49de1ce660c1