FDA EIR - Actavis Laboratories UT, Inc. - June 20, 2021

An FDA surveillance inspection of Actavis Laboratories UT, a Teva Pharmaceutical subsidiary, was conducted from August 16-20, 2021. The inspection focused on quality, production, laboratory control, and packaging/labeling systems for human drug and drug/device combination products, including Naloxone Hydrochloride Metered Nasal Spray. Conducted under regulatory guidelines such as CPGM 7356.002 for Drug Manufacturing Inspections, the inspection aimed to ensure compliance. At its conclusion, a one-item FDA Form 483 was issued to the General Manager. The primary violation, citing 21 CFR 211.122(d), pertained to the inadequate storage and segregation of pre-printed labeling materials. Specifically, preprinted cartons were observed on an upper shelf in a general raw materials warehouse area, lacking sufficient separation from other drug components. Additionally, the inspection noted concerns such as an unsanitized naloxone packaging bin, an improperly stored Doxepin HCl USP reference standard, and instances of incomplete documentation in training records and method transfer processes. Actavis Laboratories UT management acknowledged the observation and committed to submitting a written response within 15 business days, with the FDA emphasizing potential sanctions if serious conditions are not corrected.