FDA 483 - Allergan Sales LLC - July 29, 2019

Allergan Sales LLC in Cincinnati was cited for significant deficiencies in its drug manufacturing operations, particularly concerning Armour® Thyroid. The inspection revealed inadequate investigation of out-of-specification results, unscientific laboratory specifications, and a lack of validated manufacturing processes. Additionally, the firm failed to properly retest components after long storage periods, indicating systemic quality control issues.