# FDA 483 - L. Perrigo Company - Unknown Date

Source: https://www.keypedia.com/records/483/l-perrigo-company/2d02d8e2-e339-4962-8b73-49de1ce660c1

> FDA 483 for L. Perrigo Company on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: L. Perrigo Company
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

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Company: https://www.keypedia.com/companies/l-perrigo-company/47babd74-e5cb-4ab8-959e-35b9d1157e0b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4
