FDA 483 - L. Perrigo Company - February 20, 2026

From February 16 to 20, 2026, the U.S. Food and Drug Administration (FDA) inspected the Perrigo Company, PLC biopharmaceutical analytical facility in Allegan, Michigan. The inspection resulted in the issuance of Form 483, identifying a specific concern regarding data accuracy in a study report. The primary issue involved a transcription error during in vitro release testing. Specifically, the slope for a test product replicate was recorded incorrectly in the study"s data tables. This single entry error led to the subsequent miscalculation of eighteen "Test-to-Reference" (T/R) ratios, resulting in the reporting of inaccurate data regarding the product"s performance. Conducted under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, this inspection serves to notify the firm of conditions that may violate regulatory standards. Although these observations do not constitute a final compliance determination, the company is required to respond. Perrigo must either discuss objections to the findings or provide a detailed plan for corrective actions to ensure the integrity and accuracy of its future analytical reporting and data management processes.