FDA 483 - Kenvue Brands LLC - April 30, 2010

This FDA Form 483 details observations from an inspection of the Fort Washington facility, identifying significant deficiencies in their quality control unit and manufacturing processes.

The Quality Control Unit (QA) failed to ensure the enforcement of responsibilities across Analytical, Microbiological, Compliance, and Quality Assurance departments, specifically regarding the rejection of raw materials contaminated with gram-negative organisms. Overall QA and Compliance responsibilities are deficient, lacking adequate laboratory facilities for testing, neglecting review and approval of validation protocols for process and equipment changes, and failing in investigations, tracking, trending of consumer complaints, and trending of products, components (e.g., water), and complaints to assure CGMP conformance.

Key violations include the absence of written procedures for production and process controls to assure drug product identity, strength, quality, and purity. Control procedures are deficient in monitoring mixing adequacy for uniformity and homogeneity, and in validating manufacturing processes causing variability. Written production and process control procedures are not followed. Unexplained discrepancies are not thoroughly reviewed. Procedures for handling complaints are not followed. Component dispensing lacks second-person verification of weight/measure. Labeling control is inadequate. There is no written stability testing program. Laboratory controls lack scientifically sound test procedures, and adequate lab facilities are unavailable. Laboratory records are incomplete regarding instrument calibration. Written specifications for lab controls lack sampling procedure descriptions. In-process material samples are not representative. Component lots are not appropriately identified by status (quarantined, approved, rejected). Components are not microscopically examined