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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

TRIAD GROUP AND H & P INDUSTRIES RECEIVE ANOTHER FDA-483 ON MARCH 28, 2011

April 13, 2011 By Barry Friedman 1 Comment

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

April 7, 2011 By Barry Friedman Leave a Comment

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)

April 5, 2011 By Barry Friedman Leave a Comment

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 — VOLUNTARY PRODUCT RECALL AND FDA 483

March 3, 2011 By Barry Friedman Leave a Comment

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...]

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