FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11
Enclosed are three of the forty six Observations along with commentary from the 30 page Triad Group FDA 483. These three Observations focus upon the training and education within the Triad Group as noted by the FDA during their investigation. It should be observed within these Observations that the FDA has noted that individuals performing various tasks should possess the various skill sets necessary to perform their functions. The FDA questions the ability of a chemist who has limited microbiological skills to provide training to personnel.