# FDA 483 - Perrigo New York, Inc. - January 22, 2019

Source: https://www.keypedia.com/records/483/perrigo-new-york-inc/bff437a2-33ea-451a-91a2-61f1dc2b2538

> FDA 483 for Perrigo New York, Inc. on January 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perrigo New York, Inc.
- Inspection Date: 2019-01-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Perrigo New York, Inc. in Bronx, NY, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate out-of-specification stability lots and inadequate written procedures for cleaning and maintenance, specifically regarding cleaning validation and assessment of cleaning effectiveness after multiple batch campaigns. These issues indicate a lack of robust quality control and manufacturing process validation.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.keypedia.com/companies/perrigo-new-york-inc/e460cce5-5bfc-4b87-b419-819e0fc7a250

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961