How Many Dietary Supplement GMP Inspections Has FDA Performed So Far?

FDA could more than double the number of Good Manufacturing Practices (GMP) inspections it performs on dietary supplement facilities this year compared to last year. The announcement was made during a SupplySide East conference presentation in May, by Bradford Williams, manager of FDA’s Division of Dietary Supplement Programs; Office of Nutrition, Labeling, and Dietary Supplements; Center for Food Safety and Applied Nutrition.

As of April 29 of this year, FDA had performed 66 dietary supplement GMP inspections. Ultimately, the agency may aim to perform as many as 191 inspections or more by the end of this year. By contrast, FDA performed 84 total inspections in 2010.

Thus far, Williams said, based on FDA inspections, “The compliance state is pretty dismal.” He noted a 25% violation rate last year and also mentioned that FDA expects the percentage of noncompliance to increase as the agency moves on to inspecting small-size companies. (The last stage of GMP compliance, for small-sized firms, kicked in last June.)

Williams also pointed out that the agency has tried to make more tools available to make the GMP regulations easier for companies to comprehend, including publishing a concise version of the regulation to help small companies understand the rules and publishing a field inspection guide last year that outlines what FDA inspectors will be looking for during inspections, including the questions they may ask.

Williams also outlined common reasons for inspections failures: 1) no or inadequate identity testing of dietary ingredients, 2) failure to establish specifications for components, ingredients, steps and stages of manufacture, and finished product, 3) failure to conduct testing, both in process and of finished product, 4) lack of adequate master manufacturing records and batch-production records, 5) and lack of adequate corrective action plans, among others.

Finally, Williams stated that FDA views third-party GMP certifications and inspections, specifically those done by recognized organizations such as NSF International, the Natural Products Association, and the U.S. Pharmacopoeia, as helpful to FDA. However, he said, simply having third-party certifications should not make a company feel complacent. “FDA found these third-party audits were missing some key things.”

Without specifically endorsing it, he also noted that SIDI, the Standardized Information on Dietary Ingredients program created by a collection of industry associations, may also be helpful in providing companies with GMP guidance, including a standardized Certificate of Analysis to give to ingredient suppliers.
FDA inspections on average take approximately five to 10 days to conduct, Williams noted.

Vasilios Frankos, PhD, formerly FDA’s director, Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, and now senior vice president of global product science, safety, and compliance for Herbalife International, was also a conference speaker. Based on his recent experience at FDA, Frankos gave his take on GMP compliance.

“There’s more guidance available than companies are aware of,” he said. “It’s surprising how little clear understanding there is of what’s needed,” by companies both big and small.

He noted that FDA is looking to “vastly increase” the number of inspections it performs. In addition, he advised that if companies are inspected by FDA and receive a Form 483 noting noncompliance, they should respond to FDA quickly-preferably within 15 days. Once FDA has issued the 483 and has received and considered the company’s response, it may then issue a warning letter. A quick response in the meantime may indicate to FDA that a company wants to work with the agency to remedy the situation.

“Based on my experience and the responses I’ve seen, the best way to avoid a warning letter is to respond quickly to FDA. Don’t wait. The faster you respond, the more responsive FDA will be as well. I believe that 15 days should be the target for getting back to FDA; longer than that is perceived as you not being very responsive,” he said. “And when I say responsive, you have to not only say what you’re going to do, but have evidence that you’ve actually implemented it and what is the result of that.”