FDA 483 - McNeil Healthcare, LLC - January 08, 2010

An FDA inspection of McNeil Healthcare, LLC, a drug manufacturer located in Las Piedras, PR, was conducted from October 22, 2009, to January 8, 2010. The inspection, led by Investigator Jose R. Lopez and Chemist Raquel Gonzalez Rivera, identified significant quality system deficiencies.

A primary observation was the failure to submit an NDA-Field Alert Report within three working days regarding bacteriological contamination or significant changes in a distributed drug product. Specifically, in 2008, the firm received numerous musty odor complaints for Tylenol Arthritis Relief Caplets (TAR) lots 08BMC013 (27 complaints) and 08BMC020 (49 complaints), including over eight associated gastrointestinal adverse event reports. Despite organoleptic confirmation of the odor, no formal investigation was conducted, and no additional testing was performed to evaluate chemical contamination or deterioration. No field alert was generated in 2008.

Furthermore, atypical trends of uncharacteristic odor complaints and adverse events for lots 09BMC034, 09CNC036, and 09CMC040, occurring since April, June, and August 2009 respectively, were not discovered until August 3, 2009. A Contract Operations Quality Management (COQM) Investigation Report (CIR#) was only generated on September 17, 20