ANOTHER RANBAXY FACILITY IS ADDED TO EXISTING CONSENT DECREE The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical  ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now … [Read more...]
BEDFORD LABORATORIES ANNOUNCES VOLUNTARY MARKET RECALL (02/16/12)
RECALL CONDUCTED DUE TO A POST-RELEASE MANUFACTURING INVESTIGATION Bedford Laboratories, a division of Boehringer-Ingelheim announced on February 12, 2012 a recall for three lots of Cytarabine for Injection, USP. This “voluntary” market recall, announced with the knowledge of the FDA is being conducted due to a post-release investigation of the manufacturing area which … [Read more...]
BEN VENUE RECEIVES YET ANOTHER FORM FDA 483 (12/2/11)
TWELVE PAGE, TEN ITEM 483 COMPLEMENTS 483 ISSUED EARLIER IN 2011 Ben Venue Laboratories received a second audit by four FDA investigators from Nov 7 thru Dec 2, 2011 and received a twelve page Form FDA 483 with ten Observations. While several of the Observations were similar to those previously received in the May 2011 audit, new Observations were also noted as part of the … [Read more...]
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 before use. COMMENT 211.065(3) (d) and 21 CFR 211.113(a) discuss the need to test components prior to … [Read more...]
