NOTES FAILURE TO COMPLY WITH USP <797> AND STATE LAWS AND REGULATIONS BACKGROUND “Pharmacy Compounding†involves modifying commercially available products to meet the requirements of an individual patient based upon a prescription from a licensed provider. Within the State of Massachusetts, a total of 25 pharmacies meet … [Read more...]
TRIAD GROUP HARTLAND, WI FORM FDA-483 INSPECTION DATES 11/29/2010 – 1/7/11
Triad Group Hartland, WI Form FDA-483 Inspection Dates 11/29/2010 - 1/7/2011 Comment Enclosed are comments from a total of seven observations representing various Systems to include Laboratory Control, Production, and Material obtained as a subset from the forty six observations within Triad Group's recent FDA 483 which resulted in a recall of their alcohol prep pads, … [Read more...]
