# FDA 483 - Perrigo New York, Inc. - May 08, 2026

Source: https://www.keypedia.com/records/483/perrigo-new-york-inc/4cab050d-0bbf-4229-acb9-0853339e8e43

> FDA 483 for Perrigo New York, Inc. on May 08, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perrigo New York, Inc.
- Inspection Date: 2026-05-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Perrigo New York, Inc. received a Form 483 following an inspection of its Bronx, NY drug manufacturing facility, revealing significant deficiencies in environmental controls, personnel practices, equipment maintenance, and facility upkeep. Observations included inadequate air pressure control, improper gowning procedures leading to contamination risks, failure to protect cleaned equipment, and poor building maintenance with cracked floors and dislodged ceiling tiles. These issues indicate a moderate level of severity concerning GMP compliance.

## Related Documents

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- [483 - 2022-10-24](https://www.keypedia.com/records/483/perrigo-new-york-inc/8aa39dba-d2fa-41bb-a4f5-c3b04418ea0d)
- [483 - 2024-09-17](https://www.keypedia.com/records/483/perrigo-new-york-inc/82a275d5-e23f-4cc9-a122-ba0b6eb236d6)

## Related Officers

- [investigator](https://www.keypedia.com/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

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
