FDA 483 - Kenvue Brands LLC - January 12, 2006

This FDA Form 483 was issued to McNeil Consumer & Specialty Pharmaceuticals, a pharmaceutical manufacturer located at 7050 Camp Hill Rd, Fort Washington, PA 19034-2210. The inspection was conducted from January 4, 2006, to January 12, 2006. Colin F. Watts, President, was the recipient of the report.

The inspection revealed three observations related to the firm's quality system:

1. **Failure to thoroughly review unexplained discrepancies:** Investigations were not always timely or complete. * No adequate investigation determined the root cause of an unsuccessful Cleaning Validation for Ibuprofen residues from the Granulator Unit, which is still in use. * A Nonconformance Investigation (NC #) for an Ibuprofen assay Out-of-Specification (OOS) result for Children's Motrin Suspension Dye-Free lacked complete documentation and was not completed until [redacted date], despite being initiated on [redacted date]. * A Nonconformance Investigation (NC #) for foreign material in Children's Motrin Suspension did not document the reason for exceeding the required time limit by SOP [redacted], initiated on [redacted date] and completed on [redacted date]. * An investigation into an acid-stage dissolution OOS result for St. Joseph Enteric [redacted] did not document the reason for