FDA 483 - Kenvue Brands LLC - December 09, 2010

This FDA Form 483 document details observations made during an inspection of McNeil Consumer Healthcare, Division of McNeil-PPC Inc., an OTC Pharmaceutical Manufacturer located at 7050 Camp Hill Road, Fort Washington, PA 19034. The inspection was conducted from October 27, 2010, to December 9, 2010. The report was issued to Hakan Erdemir, Vice President of Operations.

The primary observation noted was a deficiency in procedures for handling written and oral drug product complaints, specifically regarding quality systems.

Key findings include: - **Complaint Categorization Issues:** During the November 6, 2009 Tylenol Arthritis Relief product recall, 131 out of 136 complaints (96.3%) reporting stomach pain, diarrhea, and/or vomiting were incorrectly categorized as "Uncategorized Adverse Event" instead of "Digestive/Gastrointestinal." Only two complaints (1.5%) were correctly categorized. - **Trending Deficiency:** The Quality Assurance (QA) unit's criterion for trending TEA-related complaints was limited to "musty/moldy" smell, despite 8 complaints (5.9%) associating this smell with gastrointestinal illness. One "musty/moldy" complaint was also miscategorized. - **Lack of Deviation Reports:** The Quality Control Unit instructed warehouse personnel to remove multiple product lots related to a