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Category Archives: Compounding Pharmacy
TESTING LABORATORY RECEIVES STERILITY OBSERVATIONS
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, … Continue reading
Posted in 483, Compounding Pharmacy, FDA Compliance, Microbiological Issues, Recall, Regulatory Compliance, Uncategorized
Tagged Accelerated Sterility Tests, anaerobes, Bacteriostatic, compounding pharmacy, Fungistasis, Growth Promotion, qualification, Sterility Tests, USP, Validation, verification
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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 Pharmacy”. The FDA indicated that the rationale behind the … Continue reading
MEDI-FARE DRUG AND HOME HEALTH CENTER, BLACKSBURG, SC RECEIVES WARNING LETTER (3/7/13)
SERIOUS DEFICIENCIES ARE NOTED IN THE PRACTICE OF PRODUCING STERILE DRUGS BACKGROUND Recently the FDA has been criticized for its management of the New England Compounding Center. The following Warning Letter represents one of the first Warning Letters that the … Continue reading
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