FDA-483 ARRIVES ONE WEEK PRIOR TO SEIZURE Comment The FDA released additional information regarding its most recent inspection (March 21 - 28, 2011) in the same press release that described its seizure of over $6 million dollars of various drug products. The five page, ten observation FDA-483 (see previous Blog on same subject) continues to demonstrate a pattern that was … [Read more...]
TRIAD GROUP RAIDED BY U.S. MARSHAL SERVICE (APRIL 4, 2011)
TRIAD GROUP RAIDED BY U.S. MARSHAL SERVICE (APRIL 4, 2011) See also new FDA-483 from March 28, 2011 (Link attached below) HARTLAND, Wis.— A medical products maker in Hartland ceased production Monday after the U.S. Marshals Service arrived to quarantine or seize materials. The Milwaukee Journal Sentinel reports H&P Industries, which makes alcohol wipes and other … [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...]
FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11
FDA 483 TRIAD GROUP OBSERVATIONS (H & P Industries) 11/29/10 -01/07/11 Comment 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 … [Read more...]
TRIAD GROUP — VOLUNTARY PRODUCT RECALL AND FDA 483
TRIAD GROUP – VOLUNTARY PRODUCT RECALL JANUARY 5, 2011 FOR IMMEDIATE RELEASE - January 5, 2011 - Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the … [Read more...]
