Dispatches from Supply Side East

GMP inspections likely to start by fall, says FDA

By Lorraine Heller

- Last updated on GMT

Related tags Dietary supplement Fda

GMP inspections likely to start by fall, says FDA
Although all medium-sized dietary supplement manufacturers in the US will be required to meet new GMP regulations as of June this year, FDA has said it is unlikely to start inspections until fall. The agency’s manager of the Division of Dietary Supplements Brad Williams talks to Lorraine Heller.

This interview follows the FDA update presented yesterday by Williams to a full audience of industry executives at the Supply Side East trade show in Secaucus.

So far, FDA has only conducted around a dozen facility GMP inspections on large firms (over 500 employees), which were required to meet the new regulations as of June 2008.

However, this figure is likely to significantly increase this year, as the majority of manufacturers (over 20 employees) become compliant.

“Our plan is to do a substantial number [of inspections] – as many as 200 firms – this fiscal year,”​ Williams told NutraIngredients-USA.com

“I can guarantee that if we find a firm that’s subject to the compliance date (…) that isn’t in compliance, we’ll take action.”

DS compliance program

In addition, Williams confirmed that FDA is currently working on the much awaited dietary supplement compliance program.

However, this will likely not contain the GMP portion, which may not be released until after June next year when the whole industry is subject to the GMP rule.

Brad Williams was speaking in place of Dr Vasilios Frankos, director of FDA's Division of Dietary Supplement Programs, who was prevented from attending SSE by a last-minute "real strong signal"​ of a problematic dietary supplement product based on AER reports submitted to the agency.

For more information on that, click here​.

Related topics Regulation GMPs, QA & QC

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