FDA 483 - Coating Place, Inc. - March 04, 2019

An FDA inspection of Coating Place, Inc. in Verona, WI, a manufacturer of pharmaceutical, dietary supplement, and food products, identified a procedural non-compliance. The firm failed to follow its own written procedures for holding and distributing operations, specifically regarding the required Quality Control signature for shipment release documentation of dietary supplements. This indicates a lapse in adherence to established internal quality control processes.