Over the past several years, the FDA has cited a number of Compounding Centers for compromised aseptic processing. Often this has resulted in only a Form FDA 483. In other cases the actions have resulted in both a Form FDA 483 as well as a subsequent Warning Letter. The Johnson Memorial Cancer Center is one of those that has been cited for both through a 483Â and a … [Read more...]
HEALTH CANADA ISSUES SUMMARY REPORT FROM AUDIT OF ID BIOMEDICAL (GSK), SAINTE-FOY, QUEBEC
Health Canada recently issued a summary report of their recent audit of ID Biomedical (GSK). Within this report, they presented summaries of both their 2012 and 2014 Inspections. Enclosed are copies of selected sections of both Inspections as well as my additional comments. “2012 INSPECTION: Health Canada's 2012 regular GMP inspection of the Sainte-Foy facility concentrated … [Read more...]
FDA Warning Letters – Their Relationship to Drug Shortages
The FDA has become keenly aware within the past several years of the impact that their audits have on the availability of drugs becoming available to the consuming public. Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this and illustrated the “FDA Response to Drug … [Read more...]
PHARMACEUTICAL FIRM RECALLS NASAL SPRAY FOR POTENTIAL MICROBIAL CONTAMINATION (10/02/13)
NEPHRON PHARMACEUTICALS APPLAUDED FOR PROACTIVE STANCE Nephron Pharmaceuticals Corporation, Orlando, FL (NPC) recalled 689,568 cartons (ten lots) of Albuterol Sulfate Inhalation Solution for oral inhalation. The recall, which was initiated by the firm and was voluntary, was caused by a “Lack of Assurance of Sterility: … [Read more...]
FIRM REPEATLY DECLINES TO RECALL ITS STERILE PRODUCTS
IS THIS THE NEW “POSTER CHILD†FOR NON-COMPLIANCE? On Friday, August 16, 2013 the FDA issued a News Release wherein it reminded “health care providers not to use sterile products from NuVision Pharmacyâ€. The FDA indicated that the rationale behind the News Release was because the … [Read more...]
