FDA EIR - Allergan Sales, LLC - February 27, 2019

An FDA inspection of Allergan Sales, LLC's Waco, TX facility, a manufacturer of sterile ophthalmic drug products, was conducted from January 29 to February 27, 2019. This follow-up inspection assessed corrections made since a 2016 inspection which had resulted in an FDA-483 and an Untitled Letter; the previous deficiencies were found to be corrected. However, the current inspection revealed three new observations documented on an FDA-483. The main issues included a failure to adequately evaluate interventions during smoke studies for Multi Dose Line (b)(4), impacting procedures to prevent microbiological contamination (21 CFR 211.113(b)). There was also a deficiency in environmental monitoring, as a risk assessment did not evaluate a specific component within the Grade A area of Multi Dose Line (b)(4) (21 CFR 211.42(c)(10)(iv)). Lastly, cleaning and disinfecting procedures for aseptic areas were incomplete, specifically lacking a reference to certain wipes used for cleaning in the Grade A area of Multi Dose Line (b)(4) (21 CFR 211.42(c)(10)(v)). Allergan's management committed to submitting a written response within 15 business days. For the cleaning procedure observation, an updated SOP was provided during the inspection to incorporate the missing details.