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

Source: https://www.keypedia.com/records/483/l-perrigo-company/57f59688-b83f-4d6c-9084-b2a2125dded1

> FDA 483 for L. Perrigo Company on October 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: L. Perrigo Company
- Inspection Date: 2019-10-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/lindsey-schwierjohann/3608e7c0-5bb9-49f0-844d-ddd6f6724fdb)
- [Investigator](https://www.keypedia.com/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

Company: https://www.keypedia.com/companies/l-perrigo-company/33abbe15-b6ff-4a2b-a8bb-563cb2a55d49

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0