FDA Threatens Germany Generic Drug Firm With Import Refusal for GDUFA Violations
The Food and Drug Administration threatened a German generic drug manufacturer with refusal of their imports at the border for failure to register and pay new fees required for generic drugs for fiscal year 2013. In a warning letter sent…
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Sept. 17, FDA said C.P.M. Contract Pharma failed to comply with self-identification and facility fee requirements set by the Generic Drug User Fee Amendments of 2012. Because FY 2013 ended Sept. 30, FDA said it will not take enforcement action for failure to identify for that year if Contract Pharma completes its FY 2014 GDUFA self-identification submission within 15 days of receipt of the warning letter.