FDA EIR - Allergan Sales, LLC - October 28, 2016

Allergan Sales, LLC, in Waco, TX, underwent a comprehensive FDA inspection from October 18 to October 28, 2016. This pre-approval and Good Manufacturing Practice (GMP) inspection focused on sterile ophthalmic finished drug products, specifically covering Oxymetazoline Cream under NDA 208552, and was conducted under relevant Compliance Policy Guidance Manuals.

The inspection revealed nine significant observations, documented on an FDA Form 483. Main violations included incomplete and missing laboratory data, particularly concerning undocumented "test injections" and a failure to thoroughly review batch failures. Deficiencies were also identified in aseptic processing area cleaning and disinfection, a lack of adequate controls for manufacturing process variability, and insufficient procedures to prevent microbiological contamination in sterile products. Additionally, the inspection noted an absence of established time limits for critical production phases, inadequate routine inspection of electronic equipment, and unrepresentative in-process samples. Other concerns included particulates originating from container-closures on production lines and unvalidated container-closure system changes.

Allergan Sales, LLC management was issued the Form FDA 483 and committed to providing a written response to the Dallas District within 15 business days to address these identified issues.