Date:
Fri, 01 May 2026 06:14:09 EDT
Content:
The U.S. Food and Drug Administration (FDA) has released a Form 483 inspection report concerning Allergan Pharmaceuticals Ireland Unlimited. The document details observations made by investigators during an inspection of the company’s facility in Ireland.
An FDA Form 483 is issued at the conclusion of an inspection when investigators identify conditions that may constitute violations of federal manufacturing regulations. These reports serve as a notice to management to implement corrective actions to ensure drug safety and quality standards are maintained.
This specific record was added to the CDER Electronic Reading Room on January 30, 2025, as part of the agency’s commitment to transparency in pharmaceutical oversight. Allergan is expected to provide a formal response addressing the observations noted in the report.
Source: FDA CDER Electronic Reading Room
Link:
http://www.fda.gov/drugs/cder-foia-electronic-reading-room/allergan-pharmaceuticals-ireland-unlimited-1302025
Keywords:
FDA, Allergan Pharmaceuticals, Form 483, Ireland, Drug Manufacturing, CDER, Inspection Report