# FDA 483 - Perrigo New York, Inc. - September 17, 2024

Source: https://www.globalkeysolutions.net/records/483/perrigo-new-york-inc/82a275d5-e23f-4cc9-a122-ba0b6eb236d6

> FDA 483 for Perrigo New York, Inc. on September 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perrigo New York, Inc.
- Inspection Date: 2024-09-17
- Product Type: drugs
- Office Name: New York District Office
- Summary: Perrigo New York, Inc. in Bronx, NY, was inspected by the FDA from September 9-17, 2024, and received a Form 483 with three observations. The inspection revealed significant issues with the firm's quality control laboratory, including inadequate out-of-specification (OOS) investigations and incomplete laboratory records. Additionally, the firm failed to follow and justify deviations from written manufacturing procedures, leading to the release of an unvalidated product.

## Related Documents

- [483 - 2019-01-22](https://www.globalkeysolutions.net/records/483/perrigo-new-york-inc/bff437a2-33ea-451a-91a2-61f1dc2b2538)
- [483 - 2022-10-24](https://www.globalkeysolutions.net/records/483/perrigo-new-york-inc/8aa39dba-d2fa-41bb-a4f5-c3b04418ea0d)

## Related Officers

- [Young K. Chou](https://www.globalkeysolutions.net/people/young-k-chou/3f34cb70-7f30-453d-9099-885e1b168975)
- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [Andrew O. Ejiofor](https://www.globalkeysolutions.net/people/andrew-o-ejiofor/6f256c75-79a4-41a0-a51b-480d5db8f3da)

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

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d