Serbian Drug Firm to Remain Under FDA Import Alert Due to Inadequate Corrective Plan
The Food and Drug Administration said Serbian drug manufacturer Hemofarm A.D. will remain on Import Alert, with its products subject to refusal of admission to the U.S., in a warning letter dated June 20 and posted to the FDA website…
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July 10. The FDA’s warning letter was in response to Hemofarm’s December 2011 response to an FDA inspection, which found, among other things: (i) insufficient standards, plans and test procedures to ensure quality and purity (for example, agar plates for recovery of microbial contamination were dry); inadequate processing techniques during water runs; etc. Hemofarm’s response lacked sufficient corrective actions, FDA said. Furthermore, Hemofarm had already failed another inspection in 2007. Therefore, FDA said, Hemofarm’s products will continue to be under Import Alert and barred from entry into the U.S.