Allergan Sales, LLC – FDA EIR, Mar 25, 2011

An FDA inspection of Allergan Sales, LLC's sterile drug manufacturing facility in Waco, TX, was conducted from March 14 to March 25, 2011. The inspection, carried out under guidelines for sterile drug process inspections, focused on critical operational systems including Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control. At its conclusion, an FDA-483 Inspectional Observations document was issued to company management, highlighting four main issues. These included inadequate design of personnel flow between Grade A and Grade B aseptic processing areas, leading to excessive entries and exits during operations. Personnel monitoring was found deficient as operators were allowed to self-sample. Additionally, written sanitation procedures were not consistently followed, and a physical defect, a detached silicone caulk, was noted in a sterile fill suite. Dermot P. Manton, Vice President/General Manager, committed to correcting these observations and providing a written response to the FDA-483, emphasizing the need for stricter adherence to manufacturing controls for product safety and quality.