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

JOINT AUDIT BY UK (MHRA) AND FRENCH (AFSSAPS) MEDICINES REGULATORY AGENCIES TOGETHER WITH FDA HIGHLIGHT ASEPTIC FILLING PROCESS DEFICIENCIES (11/7-11/11)

December 12, 2011 By Barry Friedman Leave a Comment

CHMP RECOMMENDS RECALL OF SELECTED BATCHES MFG AT BEN VENUE SUMMARY A joint GMP inspection of the Ben Venue site, where a number of sterile medicines are manufactured, by the UK and French medicines regulatory agencies together with the US FDA on 7-11 November 2011 highlighted several shortcomings in the quality management system, particularly in relation to the aseptic … [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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