FDA cGMP inspections: Keeping tabs on the bottom 5%

In three separate articles, Natural Products Insider has reported on FY23 inspectional data applicable to manufacturers of dietary supplement products. The most recent one highlighted the top five violations of the manufacturing rules incorporated in 21 CFR Part 111, based on inspections by the Food and Drug Administration.

(The first article focused on the number of FDA inspections returning to typical levels for the second year in a row, and the second story highlighted the number of foreign FDA audits).

In this column, I’m going to zero in on the “worst of the worst,” those firms classified by the Food and Drug Administration as “OAI” or official action indicated, following an FDA inspection for compliance with the cGMPs (current good manufacturing practices).

The OAI classification means FDA found objectionable conditions and recommended administrative or regulatory action.

According to the FDA data for the fiscal year ending on Sept. 30, 2023, which I obtained from a Freedom of Information Act (FOIA) request, 24 total inspections, or about 5%, were classified as OAI. Of just the 40 foreign inspections in FY23, four, or 10%, were designated OAI.

Two hundred and eight inspections were classified VAI (voluntary action indicated) and 228 were designated NAI (no action indicated).

Related:Top FDA cGMP citation in FY23 tied to product specifications

The firms with OAI status are the ones susceptible to receiving an FDA warning letter and, if the cGMP issues still aren’t resolved to the satisfaction of FDA, possibly a call one day from the Department of Justice alerting them to a pending enforcement action in federal court requesting an injunction.

For this column, I’m deliberately not identifying those 24 firms designated OAI. We will have follow-up news coverage examining a select number of them to try to better understand what’s gone wrong, how FDA plans to deal with these firms and obtain comments from the companies themselves for a more balanced view.

According to the FDA data, at least one manufacturer classified as OAI was cited for 22 cGMP violations. (For some context, companies that received a 483 in FY23 were cited for an average of 5 observations). Obviously, that company has its work cut out in responding to the investigator’s mountain of observations in the Form 483.

The good news: If one wishes to avoid FDA’s wrath—and negative publicity stemming from a 483 or warning letter—cGMP resources are aplenty.

Just this week, my email was populated with announcements about cGMP events, including one from the Council for Responsible Nutrition (CRN) regarding a two-part virtual training on Jan. 23-24, in partnership with NSF.

Related:FDA inspections of dietary supplement facilities back to typical levels for second year

Meanwhile, the United Natural Products Alliance (UNPA) has announced a Jan. 18 webinar on “The Four Horsemen of GMPs: Identity, Purity, Strength and Composition,” with consultant Marian Boardley and James Kababick of Flora Research Laboratories.

“Establishing final product specifications for dietary supplements can be a complex and challenging undertaking,” the UNPA email noted. “Historically, a significant proportion of FDA 483 warning letters have been attributed to specification issues related to identity, purity, strength and composition.”

Indeed, my story earlier this week noted the most common “observation” or violation of the cGMPs was tied to a requirement in 21 CFR 111.70(e)—that manufacturers establish product specifications for identity, purity, strength and composition, and limits on contaminants.

Based on its limited resources, FDA only inspects on average 500 to 600 supplement firms annually. The industry has work to do to ensure the 5% OAI figure decreases and doesn’t get any bigger.