McNeil Consumer Healthcare - December 9, 2010
Issue Date
Dec 09, 2010
Region
Central
Category
Drug
$117.00
Address 1
7050 Camp Hill Rd.
City
Fort Washington
State
PA
Zip/Postal Code
19034
Country
US
Inspection Range
Oct 27, 2010 - Dec 09, 2010
Pages
16
First Observation
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Specifically, written complaint procedures that were in effect during November 6, 2009 Tylenol Arthritis Relief product recall require the complaint category assigned to a complaint file be an accurate description of the event as transcribed from the reporter of the event.
Investigator(s): Joseph L. Despins, Linda M. Hoover, Anita R. Michael, and Temar Q. WilliamsSpecifically, written complaint procedures that were in effect during November 6, 2009 Tylenol Arthritis Relief product recall require the complaint category assigned to a complaint file be an accurate description of the event as transcribed from the reporter of the event.