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FDA Data: Supplement cGMP Compliance Rates Show Modest Improvement

by Josh Long -

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Reasons for Noncompliance

Consultants and lawyers have suggested some firms may have not lived up to cGMP standards because compliance is expensive.

Cirotta cited a "lack of financial and personnel resources" as common reasons for noncompliance with cGMPs.

"It is not an inexpensive regulation to comply with," Mister acknowledged. "It has its costs, but the tradeoff is by having GMPs, we are producing products consistently that consumers know they have what they are supposed to have."

Shaw cited a number of reasons for firms receiving a Form 483, including the complexity of regulations that feature "many nuances," differences of opinion between the inspector and the company, and relatively minor violations.

"More disconcerting however, is the number of inspections and Form 483s that result in warning letters or other official enforcement actions," he said.

FDA Enforcement Action

According to data FDA ran on Sept. 5, 2013 and presented by Fabricant at a U.S. Pharmacopeial Convention in September 2013, 117 of 350 inspections that were expressly designated under an FDA code as falling under dietary supplement cGMPs, or 33 percent, were classified by the FDA district office overseeing the inspection as official action indicated (OIA). The classification doesn't necessarily mean FDA will take an enforcement action against a company, such as issuing a warning letter or seeking an injunction in court, Fabricant explained, but it reflects the agency's opinion that enforcement action is justified.

"The plan is to get back to firms when you find violations in a quick manner," Fabricant said. "Does it always happen? No, generally because of [limited] resources and priorities."

In FY13, FDA sent approximately 70 warning letters to dietary supplement firms for violations of regulations, including cGMPs, according to the agency. The figure excludes warning letters sent to firms that allegedly made claims rendering their products drugs.

One hundred and forty three inspections explicitly falling under the cGMPs, or 41 percent, were classified as voluntary action (VAI). The classification means observations were cited, and FDA is giving a company an opportunity to come into compliance, Fabricant said. The classification does not necessarily mean FDA has reinspected a firm and found no existing problems.

"It's not a compliant inspection, not by any means," Fabricant said, commenting on the VAI classification.

Dietary supplement firms have 15 days from receipt of a Form 483 to respond to FDA. The agency could not provide figures on the number of dietary supplements that responded to a Form 483 in FY13. According to FDA, that information is not captured in its data systems.

Young, the lawyer from Kleinfeld, Kaplan & Becker, said FDA generally doesn't let a firm know whether it considers a response to a Form 483 adequate. He said FDA usually conducts a follow-up inspection the following year or later to confirm a company addressed observations that were identified during the previous visit.  

However, Young said some FDA districts provide a supplement firm what is known as an "establishment inspection report," typically signaling the agency does not intend to take further enforcement action.

"The districts are different with regard to whether they routinely send out establishment inspection reports," he said. "Some of them do rather routinely and others of them just don't."

Roughly 26 percent of inspections in FY13 that were expressly designated as falling under the cGMPs were classified as no action indicated (NAI), according to Fabricant. Firms that were not issued a Form 483 or that were cited with only a few, relatively minor observations are likely to fall into this category.

The numbers presented by Fabricant at the USP convention encompass OAI, VAI and NAI classifications for several months of FY13.

Some industry sources have argued the number of firms adequately responding to a Form 483 is a more accurate gauge of the industry's compliance with cGMPs. But FDA reminded industry that even a timely and full response to a Form 483 doesn't mean FDA would find in a subsequent inspection that the company is in full compliance with cGMPs.

If a company lacks specifications, what good is a response to a Form 483, Fabricant asked.

According to an FDA compliance manual, the agency will submit close-out letters to firms following the issuance of a warning letter if it confirms the violations have been adequately addressed and other conditions have been satisfied. FDA typically confirms that observations have been corrected by conducting a follow-up inspection, the manual states. FDA issued two close-out letters to dietary supplement firms in FY13, according to the agency.

"I think everyone likes to get what they paid for," Fabricant said, commenting on consumers' expectations and the role of the cGMPs. "I would hope people get the message that we are taking things seriously."

Some industry executives, including a former FDA official who oversaw drafting of the cGMPs, said the message is clear.

"The FDA is certainly not taking its foot off the gas as far as inspecting and really continuing to make GMP compliance if not the number one priority, certainly at the top of things it's concerned about," said Bill Frankos, Herbalife Ltd.'s senior vice president of global product science, safety and compliance.

To access resources on cGMPs, check out INSIDER's Dietary Supplement GMP Quality and Compliance Center.
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