FDA 483 - Kenvue Brands LLC - March 09, 2000

This FDA Form 483 was issued to McNeil Consumer Healthcare, a drug manufacturer located at 7050 Camp Hill Road, Fort Washington, PA 19034. The inspection period was from February 9-11, 14-18, 24, 28, and March 1-3, 8, 9, 2000.

The inspection revealed 13 observations:

1. Process deviations from ANDA 73-019 were observed in compression batches, including variations in granulation batch usage and incomplete batch processing. 2. Reconciliation records for Motrin IB core compression batches were unclear regarding granulation utilization, samples, and waste. 3. Failures and deviations in process validation batches were not documented or investigated by Quality Assurance. 4. Hold times were not established for bulk Imodium AD Liquid before packaging, and for unfinished oral dosage form cores before coating and packaging. 5. Qualifications for a specific system were incomplete; the final report was not prepared as required, and QA review was delayed. No justification for cleaning this system was provided. 6. Calibration of scales for mixing tanks was inconsistent, and written procedures were not specific to the range of use. 7. No justification for cleaning a dedicated piece of equipment was provided. 8. SOPs for mixer calibration were not followed; specifications were not printed on work