FDA 483 - Kenvue Brands LLC - July 07, 2017

During an inspection, Johnson & Johnson Consumer Inc. in Lititz, PA, was cited for failing to reject drug products that did not meet established standards and specifications. Specifically, an active pharmaceutical ingredient (API) with an out-of-specification (OOS) assay result was released into production. This OOS material was subsequently used to manufacture finished Listerine Naturals Antiseptic batches.