FDA Warns 3 Drug Compounders Over Sloppy Practices
Law360, Washington (March 4, 2014, 7:44 PM EST) -- The U.S. Food and Drug Administration on Tuesday released three warning letters it sent to drug compounding pharmacies, slamming all three for unsanitary conditions at their facilities and two for producing drugs without individual prescriptions.
Nora Apothecary and Alternative Therapies Inc., Pallimed Solutions Inc. and Wedgewood Village Pharmacy Inc. all received FDA warnings detailing the shortfalls in their sterile facility procedures, which ranged from visible sterile drug contamination to inadequate clean room facilities and monitoring programs.
In particular, Pallimed received the most the scathing FDA review, which noted that approximately 56 inspected vials contained “white filamentous material and black floaters” and...
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