TRIAD GROUP MUST AWAIT AN ACCEPTABLE QUALITY ASSURANCE AND QUALITY CONTROL PROGRAM BEFORE RESUMING MANUFACTURING AND DISTRIBUTION Comment The FDA entered into a Consent Decree of Condemnation, Forfeiture and Permanent Injunction against H&P Industries that would prevent them from manufacturing and distributing products from their Hartland, WI facility. Under the decree, … [Read more...]
TRIAD GROUP AND H & P INDUSTRIES RECEIVE ANOTHER FDA-483 ON MARCH 28, 2011
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...]
FDA ORDERS SEIZURE OF TRIAD PRODUCT WORTH $6 MILLION
FDA Orders Seizure Of Antiseptic, Antifungal Products Worth $6 Million The AP (4/6) reported that the Food and Drug Administration "said Wednesday that antiseptic products made by Triad Group and H&P Industries were seized to prevent the distribution of products that might be contaminated and pose a health risk." At the FDA's request, US Marshals seized more than "$6 … [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...]
