FDA EIR - Kenvue Brands LLC - July 07, 2017

An FDA cGMP inspection of Johnson & Johnson Consumer Inc.'s Lititz, PA facility occurred from July 6-7, 2017. Conducted under the CP7356.002 Drug Manufacturing Inspections framework, the inspection evaluated the Quality, Production, and Facility & Equipment Systems. The primary violation identified, documented on a Form FDA 483, concerned the failure to reject drug products not meeting established standards and specifications, specifically referencing 21 CFR 211.165(f). The main issue involved Active Pharmaceutical Ingredient (API) Natural Thymol Lot# 409640, which registered a confirmed out-of-specification (OOS) GC assay result of 97.4%. Despite this, the non-conforming lot was released and used in the production of finished Listerine Naturals Antiseptic Batches #2766LZ and #2776LZ. In response, company management committed to implementing immediate corrective actions and submitting a formal written response to the Philadelphia District Director.