Tag Archives: Triad Group

ZHEJIANG JIUZHOU PHARMACEUTICAL CO. RECEIVES IMPORT ALERT (3/18/14)

FDA PROVIDES NO RATIONALE FOR ALERT After the Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co. was published in a recent Blog (8/20/14), several of my colleagues sent me comments regarding this Chinese Active Pharmaceutical Ingredient (API) source. They were particularly … Continue reading

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VAGINA COSMETICS RECALLED FOR CONTAINING MICROORGANISMS AND BENZOCAINE

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)

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

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

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)

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

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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