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 CDER has issued a new Draft Guidance as well as a slide deck from B. Uratani, … [Read more...]
Ranbaxy Labs Gets A Sweeping Consent Decree (01/25/12)
RANBAXY REQUIRED TO PAY $500 MILLION FINE COMMENT Ranbaxy Laboratories entered into a Consent Decree with the FDA on January 25, 2012 wherein they agreed to pay a $500 million fine and accept changes to plants both within the US and India. This Blog has previously reported on a number of on-going issues to include the falsification of data … [Read more...]
AMERICAN NATIONAL RED CROSS RECEIVES ADVERSE DETERMINATION LETTER (1/13/12)
FAILURE OF THE ARC TO MEET REQUIREMENTS YIELDS OVER 9 MILLION DOLLAR FINE From April through October 2010, United States Food and Drug Administration (FDA) investigators inspected sixteen American National Red Cross (ARC) Blood Services facilities and observed significant violations of the law, regulations, and the Amended Consent Decree of Permanent Injunction, entered on … [Read more...]
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 include Staphylococcus lentus, S. sciuri, Bacillus lentus, Alloiococcus otitis, … [Read more...]
