FDA Warns German Drug Company of Import Refusal for CGMP Violations
The Food and Drug Administration threatened to refuse entry of German drug manufacturer Hameln Pharmaceuticals’ drug products for current good manufacturing practice regulation violations, it said in a warning letter (here). The refusal would only apply to the company’s Hameln,…
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Germany facility, the agency said. FDA may also withhold approval of new applications or supplements listing Hameln Pharmaceuticals as manufacturer if the violations aren’t corrected.