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Fabricant on GMPs: ‘There is not a clear indication there will be a drop in non-compliance anytime soon, and that concerns us’

By Stephen Daniells, 13-Nov-2012

Related topics: Regulation, GMPs, QA & QC, NDI draft guidance

Strong enforcement from FDA on cGMPs (current good manufacturing practices) will continue, says FDA’s Dr Daniel Fabricant, but given that many GMP basics are still not being met and the Agency's limited resources, many of the issues seen today may still be around in 5 or 10 years. 

Speaking with Stephen Daniells at the recent SupplySide West show in Las Vegas, Dr Fabricant, Director of FDA’s Division of Dietary Supplement Programs, said that the industry will see a lot more strong GMP enforcement action like injunctions and seizures.

“It sends a good message if we can take swift, effective, strong enforcement action. I hope it gives those people [who are flouting GMP regulations] a moment of pause.”

“I can’t emphasize greatly enough that I hope people move away from the mentality that FDA is just a traffic cop handing out tickets.”

Commenting on the potential next wave of potential issues related to GMPs, Dr Fabricant said that finished product testing and reference materials are issues that he expects to see a lot more of in the future.

“We’re five years out [from the introduction of GMPs]. This didn’t happen yesterday. The other question you ask is, ‘What were people doing before? Shouldn’t there have been level of products meeting spec?’

“Given that we’re still not finding the basics being adhered to in a lot of these cases, I fear that in five to ten years, given our limited resources and priority challenges, we may still be seeing some of the same issues.”