FDA EIR - Allergan Sales, LLC - October 08, 2015

An FDA inspection of Allergan Sales, LLC in Waco, TX, was conducted from September 14 to October 8, 2015, following previous concerns regarding mold complaints in their Carboxymethylcellulose (CMC)/Purite ophthalmic products, including Refresh Tears. The inspection identified five significant observations indicating deviations from regulatory standards for drug manufacturing.

Key issues included an inadequate written stability program that failed to provide sufficient proof of antimicrobial effectiveness for the Purite preservative throughout the products' expiry, particularly under actual consumer use conditions. This deficiency was especially critical given the history of recurrent mold complaints. The inspection also highlighted shortcomings in laboratory controls, noting a lack of scientifically sound test procedures for ensuring product quality and purity, as well as unjustified data retesting and invalidation. Additionally, the facility was cited for using non-sterile, industrial-grade grease near open sterile drug products, inappropriate clothing for manufacturing personnel, and an insufficient system for monitoring environmental conditions in aseptic processing areas.

Allergan management committed to evaluating new methods for investigating product complaints, including designing experiments to study the impact of simulated market storage conditions and potential product misuse. The company also stated its intention to provide a written response to the agency within 15 business days addressing the identified observations.