FDA 483 - Kenvue Brands LLC - June 07, 2004

On June 7, 2004, the FDA issued a Form 483 to McNeil Consumer & Specialty Pharmaceuticals, a human drug manufacturer in Fort Washington, PA, following an inspection from May 17 to June 7, 2004. The inspection revealed 14 observations related to quality system, packaging, laboratory, facilities and equipment, and materials handling.

Key violations include: - **Quality System:** Failure to thoroughly review unexplained discrepancies, including untimely, incomplete, or undocumented investigations for issues like broken caplets, incorrect dosing, weighing errors, and contamination. Investigations often lacked documentation of quality review, evaluation of retained samples, or assessment of other potentially affected products. Annual product reviews were deficient, not including evaluations of returned goods, complaints, or all investigations. - **Packaging System:** Reprocessing was performed without quality control unit review and approval, and batch production records lacked complete information (e.g., scale set-up documentation, complete batch numbers on uncontrolled records). Labeling control was inadequate, with access not restricted to designated personnel, and incoming label inspections were only conducted on the first receipt of a vendor lot. - **Laboratory System:** Laboratory records lacked essential details like sample quantity, source, and dates. Alert level specifications for purified water were not evaluated or adjusted based on historical data. - **Facilities and Equipment System:** Written procedures for equipment cleaning and maintenance were not followed, as evidenced by exceeded dirty hold times for liquid holding