FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013. Their five investigators issued a five Observation, twelve page document. Enclosed is Observation 1 which … [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...]
FRANCK’S PHARMACY RECALLS ALL STERILE HUMAN AND VETERINARY PRESCRIPTIONS FROM NOV 21, 2011 TO MAY 21, 2012
ENVIRONMENTAL SAMPLING OF CLEAN ROOM REVEALED PRESENCE OF MICROORGANISMS AND FUNGAL GROWTH BY FDA. WHAT HAPPENED TO USP <797>? Franck's Pharmacy, Ocala, Florida initiated a recall of all sterile human and veterinary prescriptions from November 21, 2011 through May 21, 2012. This recall follows an earlier recall (May 2, 2011 Notice of Recall, … [Read more...]
