FDA INCLUDES THREE EUROPEAN FACILITIES TO INCLUDE MERCK SERONO S.A., AUBONNE, SWITZERLAND WITH MEDIA FILL ISSUES The FDA released on Wednesday, February 17, 2012 a Warning Letter that was sent to Merck KGaA on December 15, 2011. Within the Warning Letter the FDA advised Merck KGaA management of deficiencies at three separate facilities, two in Switzerland and one in Rome, … [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...]
H&P’s ANATOMY OF A CONSENT DECREE (01/24/12)
H&P INDUSTRIES FULFILLS ITS INITIAL OBLIGATIONS AND RECEIVES RETURNED BOND H&P Industries has a recent history of receiving significant Form FDA 483s from the FDA. The consequence of these various recalls and 483s ultimately led to a seizure of raw materials, in-process product and final product by U.S. Marshalls. Subsequent to that H&P Industries entered into a … [Read more...]
LEARN ABOUT THE FORM FDA 483s THAT LED TO THE NOVARTIS RECALL (1/08/12)
SPECIFIC OBSERVATIONS POINT TO THE EVENTUAL LINCOLN, NE RECALL Novartis Consumer Health, Inc. (NCH) received a Form FDA 483 containing 10 Observations representing 23 pages on January 20, 2012. Several of the Observations were similar to those received in July 2011. Observation 1 is the most inclusive and reads as follows: “OBSERVATION 1 QUALITY SYSTEM: Your Quality Unit … [Read more...]
FDA CDER PUBLISHES SEVERAL NEW PRESENTATIONS TO ASSIST WITH REGULATIONS GOVERNING PET DRUG PRODUCTS
DOCUMENTS INCLUDE AN EXTENSIVE SLIDE DECK AND PROPOSED Q & A The FDA has been quite busy since the issuance of the new 21 CFR 212 entitled "Current Good Manufacturing practice for Positron Emission Tomography Drugs" (December 2011) which covers Positron Emission Tomography (PET) Drug Products. CDER has issued a new Draft Guidance as well as a slide deck from B. Uratani, … [Read more...]
