SHOULD THE FDA BE DOING MORE? Recently the New England Compounding Center (NECC) was found to have dispensed a number of syringes containing methylprednisolone acetate to treat pain control and inflammation. Following a number of reports from various states, the FDA and CDC became involved in attempting to locate the source of … [Read more...]
DPT LAKEWOOD, LLC LAKEWOOD, NJ RECEIVES FDA WARNING LETTER (08/27/12) FOR STERILITY FAILURES
DPT Lakewood, LLC was inspected between February 15 through March 7, 2012. During this audit the FDA found that Santyl Ointment to be adulterated and that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed … [Read more...]
FDA WORKS WITH VARIOUS VENDORS DURING SANOFI PASTEUR’S INABILITY TO PRODUCE THERACYS BCG DUE TO BIOLOGICAL PRODUCT SHORTAGE
COMMENT The FDA is often criticized because it is viewed as creating biological and drug product shortages when it issues a FDA 483, Warning Letter, Consent Decree or executes a seizure. This Alert published by the FDA demonstrates several of the actions that the FDA may initiate to minimize these shortages. In addition, the FDA now typically adds a "boilerplate" paragraph … [Read more...]
NEW ADDITION TO WARNING LETTERS’ “BOILERPLATE” PARAGRAPHS
CDER RESPONDS TO MANAGEMENT OF LACK OF AVAILABILITY OF FINISHED DRUG PRODUCT OR API Recently the FDA has added a new standardized paragraph to each of its Warning Letters for both Finished Drug Products and for Active Pharmaceutical Ingredients. Please review how the FDA desires you to respond. "If, as a result of receiving this Warning Letter or in general, you … [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...]
