By Frank Angst
Dr. Robert MacKay, veterinarian at the University of Florida's Large Animal Medicine, said eight Thoroughbreds given a single dose of a compounded drug, toltrazuril/pyrimethamine, to treat equine protozoal myeloencephalitis (EPM) at a training stable in Ocala, Fla., had neurological disturbances within 36 hours of administration.
Cariny Nunez of the U.S. Food and Drug Administration's Miami office confirmed the FDA also is looking into the horse deaths and any link to the compounded drug.
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2 comments:
Firm Name
STREET ADDRESS ·Leiter's
Cambrian Park Drugs, Inc ., dba
1700 Park Ave Leiter's Pharmacy
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questions, please contact FDA at the phone number and address above.
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
Each batch of drug product required to be !tee ofobjectionable microorganisms is not tested through appropriate laboratory
testing.
Specifically, your firm did not provide any data to demonstrate that your product, Brilliant Blue G 020 0.025%, is sterile and/or pyrogen free.
a.
The sterility testing performed by the contract laboratory consist of: Aerobic and Anaerobic Bacteria, and Fungi (Mold and Yeasts). Your finn provided no data to demonstrate that the test method is suitable for your sterile drug product, Brilliant Blue G 020 0.025%. In addition, the Certificate ofAnalysis from your contract laboratory indicates that the sterility testing "does not meet all the requirements for sampling and/or method suitability specified in USP <7 I>" which ensures the specific product tested for sterility did not give a false negative result due to product inhibition.
b.
Your firm has not established the specification for endotoxin product release testing for Brilliant Blue G D20 0.025%. According to your Laboratory Manager, as long as the associated CCJtificate of Analysis are provided from the contract laboratory, the finished product lots are approved and released for distribution irrespective ofthe endotoxin test results. She stated that she assumes the contract laboratory would only sends Certificate of Analysis with acceptable results.
OBSERVATION 2
Procedures designed to prevent microbiological contami.nation ofdJUg products purporting to be sterile do not include adequate validation ofthe sterilization process.
Specifically,
a.
Your firm's SOP 2.030, entitled Sterile Compounding Personnel Qualification, Version 1.0, dated, effective date of 03/01/09, requires each employee shall be evaluated on his or her designated aseptic process a minimum ofever.
Specifically but not limited to the following, your firm has never performed fin ished product potency testing on Brilliant Blue G D20 0.025%. Between November 2011 and January 2014, 14 lots of Brilliant Blue G D20 0.025% manufactured and d istributed by your firm were not tested for potency.
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