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

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.