Agency Increasing Number of Supplement Inspections, Says Fabricant
Posted 10 May 2012 | By
The number of inspections conducted by the US Food and Drug Administration (FDA) is increasingly rapidly as the agency moves to crack down on violators of quality regulations, the Director of FDA's supplement program said, reports Natural Products Insider.
Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs, said the agency is starting to use its authorities more aggressively-something Regulatory Focus took note of in April 2012 and May 2012.
Fabricant said in April he was "aghast at the degree of non-compliance" with current good manufacturing practices (cGMPs), and added the agency was "seeing some of the same mistakes from warning letter to warning letter."
"That's concerning," Fabricant said at the time.
Fabricant added to those remarks while attending the American Herbal Products Association's Botanical Congress in May, explaining the agency plans to continue an aggressive push against quality infractions.
"It won't be the last time we use those authorities," said Fabricant. "It's something to be mindful of. It's something we take very seriously, as you've seen from the actions."
Companies are frequently violating the same cGMP regulations, said Fabricant, including failing to establish batch records, specifications, manufacturing records, quality control procedures or quality assurance procedures.
"GMPs (are) the biggest challenge ... facing the dietary supplement industry, at least that's the way the regulators see it, and we hope everyone understands that," Fabricant said.
Natural Products Insider - FDA Will Increase Inspections, Product Seizures
Regulatory Focus - FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers
Regulatory Focus - Six Dietary Supplement Manufacturers Cited by FDA for Promoting Unproven Claims, cGMP Violations
Regulatory Focus - FDA Sends out Warning Letters to Supplement Manufacturers