IN-HOUSE STERILITY TESTING METHOD NOT EQUIVALENT TO USP<71> During the time frame of June 4 - 14, 2012, the Hameln facility was audited by the FDA. Following the audit, the firm responded on July 4, August 2 and 31, and September 8, 2012. Even with all of these responses, the FDA found that the firm lacked sufficient corrective actions. For … [Read more...]
PERFORMANCE PRODUCTS INC, ST LOUIS, MO RECEIVES WARNING LETTER (11/20/12)
COMPANY FAILS TO REPLY TO FORM FDA 483 FROM JULY 2012 AUDIT Compliance Products, St. Louis, MO was audited by the Kansas City office of the FDA from July 16-20, 2012. Following the audit, a total of eight Observations were issued. As of the date of the Warning Letter, no response had been received by the FDA. Many of the Observations represented recurring Observations – … [Read more...]
TOP POSTINGS FROM THE BLOG OF BARRY A. FRIEDMAN, Ph.D., LLC — 2012
Often the question is asked "what were your top postings during the previous year. This is an intriguing question since I don't know myself until I review the postings at the end of each year. With an accumulation of over 70,000 views, it is of interest to determine what you, the viewers, deemed to be the most important. I have now sorted through the … [Read more...]
NEW ENGLAND COMPOUNDING CENTER (NECC) DECLARES BANKRUPTCY
The CBS Evening News (12/21, story 9, 0:25, Pelley) reported "The specialty pharmacy linked to that deadly meningitis outbreak filed for chapter 11 bankruptcy protection today." NBC Nightly News (12/22, story 7, 0:25, Holt) added that the Framingham, Massachusetts-based specialty pharmacy "is facing 130 … [Read more...]
FDA APPROVES RAXIBACUMAB TO TREAT INHALATION ANTHRAX (12/14/12)
FIRST MONOCLONAL APPROVED UNDER FDA'S ANIMAL EFFICACY RULE The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or … [Read more...]
