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,…
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
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.