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 Agency has issued in a similar area since the issue of Compounding Pharmacies has become a national topic.
The document highlighted below provides insight as to how the FDA is now managing this problem. Of note is the fact that even though the State of South Carolina lifted a suspension of Medi-Fare’s pharmacy license, the FDA, in a teleconference with the Client “informed you (the Client) that you should not resume production of sterile drugs until you implement appropriate corrective actions”.
“Between December 10, 2012, and January 18, 2013, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Medi-Fare Drug and Home Health Center, Inc., located at 300 W. Pine Street in Blacksburg, South Carolina 29702. During the inspection, the investigator noted that you were not receiving valid prescriptions for individually-identified patients for a significant number of drug products you were producing. In addition, the investigator observed serious deficiencies in your practices for producing sterile drug product, which could lead to contamination of the products, potentially putting patients at risk. These observations and others were noted on an FDA Form 483 issued on January 18, 2013. We acknowledge receipt of your firm’s letter to FDA dated December 12, 2012, as well as your firm’s response to the FDA Form 483 dated January 29, 2013.continue reading here
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