Supplement firms must refine their process of collecting, classifying and filing product complaints to comply with good manufacturing practices, FDA's Bill Frankos says.

"I think from early observations, this doesn't seem to be going on as systematically as I'd hoped," said Frankos, director of the Division of Dietary Supplement Programs within FDA's Center for Food Safety and Applied Nutrition.

Companies need to separate complaints about product quality - which may reflect GMP compliance problems - from health-related complaints - which, if warranted, must be reported to FDA as serious adverse events.

Quality control plays a central role in classifying and acting on complaints, Frankos said at the SupplySide West conference and trade show Nov. 12 in Las Vegas.

"Your QC staff has to do a specific evaluation of the complaint and any action that they have taken to mitigate that problem," he said. "And it has to be documented."

Upon entering a facility, a GMP inspector should have access to complaint files that are segregated into serious AERs, non-serious AERs and product quality issues, Frankos said.

Even a simple resolution to a problem, such as recalibrating a label printer to fix crooked and illegible labels, should be recorded, he said.

Separately at SupplySide, Amy Caplette of Nutrilite Products discussed her firm's experience with a GMP inspection and emphasized the importance of being prepared to discuss recordkeeping practices.

"We spent about two hours talking about product recalls and customer complaints" with the inspector, said Caplette, a group leader of quality assurance for the Amway Global subsidiary.

She said leading up to the inspection, Nutrilite had a policy for recording and acting on consumer complaints, though "it was kind of disjointed" because the submissions were handled in a separate facility.

In anticipation of GMP inspections, another supplement firm, Pharmavite, improved communication between its consumer affairs and quality control groups to facilitate better handling of complaints, an executive said in a 2008 interview (¹ Also see "GMP Compliance Builds As Industry Priority While FDA Sorts Out Its Own" - Pink Sheet, 28 July, 2008.).

A Self-Guided Tour Through GMPs

As GMP implementation enters the final phase, FDA essentially has left it to industry to comply or face the consequences of a failed inspection.

Firms with fewer than 20 employees must comply with GMPs by June 25, 2010.

Supplement companies may gain insight into GMP expectations by perusing the establishment inspection reports in the Office of Regulatory Affairs' ² electronic reading room. FDA posts documents that elicit high demand through Freedom of Information Act requests.

Short of that, however, Frankos said plans for future FDA guidance regarding GMPs are fairly modest. CFSAN is compiling a Q&A document based on questions CFSAN has received from industry over the past two years, he said.

Another document long in gestation, a compliance guide for small supplement companies, has been delayed due to a lawsuit filed by frequent agency critic Jonathan Emord (³ Also see "GMP Inspections Under Way in Southwest Region: “Be Ready,” Says FDA" - Pink Sheet, 27 October, 2008.).

"We're waiting for our litigators to let us release that," Frankos said. "But that's the only guidance we're planning."

Emord, of Emord & Associates in Clifton, Va., filed a complaint in federal district court in August alleging that supplement GMPs violate the Dietary Supplement Health and Education Act and that FDA has provided insufficient guidance to firms (⁴ 'The Tan Sheet' Aug. 10, 2009, In Brief).

In an e-mail, Emord called it "bitterly ironic" that the agency declines to issue a compliance guide on the basis of his suit.

"FDA is keeping what constitutes GMP compliance in a state of obscurity, playing an unnecessary, costly and unlawful game of 'gotcha' with the dietary supplement industry," he said.

- Dan Schiff ( ⁵ d.schiff@elsevier.com )

FDA's Frankos Grades GMP Complaint Recordkeeping "Needs Improvement"

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