Tag Archives: Triad Group

VAGINA COSMETICS RECALLED FOR CONTAINING MICROORGANISMS AND BENZOCAINE

Posted on January 22, 2012 by

EFFECT OF MICROBIAL CONTAMINATION DIFFICULT TO ASSESS COMMENT USA Far Ocean Group issued a voluntary recall following FDA’s laboratory analyses of “Vagifresh Gel” and “Vagifresh Ball”.  The former contained benzocaine, while the later contained bacteria from a number of species to … Continue reading →

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PROFESSIONAL DISPOSABLES INTERNATIONAL, INC, ORANGEBURG, NY RECEIVES FORM FDA 483 (7/5/11)

Posted on October 12, 2011 by

BACILLUS CEREUS RECOVERED FROM APPLICATOR USED TO MANUFACTURE NON-STERILE ALCOHOL PREP PADS OBSERVATION 1 Each lot of a component that is liable for microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests … Continue reading →

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SECOND WIPE-MAKER ISSUES RECALL AFTER BACTERIA DETECTED

Posted on September 21, 2011 by

NON-STERILE WIPES RECALLED ON SEPTEMBER 16, 2011 FOLLOWING DISCOVERY OF LOW LEVELS OF BACILLUS CEREUS COMMENT Bacillus cereus was recently identified within non-sterile alcohol prep wipes manufactured by Professional Disposables International Inc (PDI), Orangeburg, NY.  The recall of five lots … Continue reading →

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H and P Industries Lawsuit Ties Tainted Wipes to Twin’s Brain Damage

Posted on July 11, 2011 by

MSNBC Reports On On-Going Rare Bacterial Infection Stumped Experts Until News Of Contaminated Products Surfaced For nearly four years, a bacterial infection that left a Seattle-area newborn with severe brain damage while his twin brother developed normally has remained a … Continue reading →

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FDA ENTERS CONSENT DECREE WITH H AND P INDUSTRIES (TRIAD GROUP)

Posted on June 14, 2011 by

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 … Continue reading →

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

Posted on April 13, 2011 by

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 … Continue reading →

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FDA ORDERS SEIZURE OF TRIAD PRODUCT WORTH $6 MILLION

Posted on April 7, 2011 by

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 … Continue reading →

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TRIAD GROUP RAIDED BY U.S. MARSHAL SERVICE (APRIL 4, 2011)

Posted on April 5, 2011 by

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 … Continue reading →

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TRIAD GROUP HARTLAND, WI FORM FDA-483 INSPECTION DATES 11/29/2010 – 1/7/11

Posted on March 23, 2011 by

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 … Continue reading →

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TRIAD GROUP — VOLUNTARY PRODUCT RECALL AND FDA 483

Posted on March 3, 2011 by

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, … Continue reading →

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