Allergan Sales, LLC – FDA EIR, Apr 13, 2012

An FDA inspection of Allergan Sales, LLC in Waco, TX was conducted from April 9-13, 2012. The inspection, covering human drug and medical device manufacturing, focused on the Quality and Production systems. It was performed under regulatory frameworks including Abbreviated Drug Manufacturing and Sterile Drug Process Inspections, as well as Drug Quality Reporting and NDA Field Alert Reporting protocols. Crucially, the inspection concluded with no significant deficiencies observed, and no FDA-483 (Notice of Inspectional Observations) was issued. This positive outcome indicates that the firm had effectively corrected all four observations noted during the previous inspection in March 2011, which included issues related to personnel flow, monitoring practices, sanitation procedures, and structural flaws in sterile filling areas. All reviewed profile classes were deemed acceptable. Consequently, no new regulatory actions were required from Allergan Sales, LLC as a result of this inspection.