GMP compliance improving based on expert's analysis of 483 issues & inspection outcomes

By Hank Schultz contact

- Last updated on GMT

GMP compliance improving based on expert's analysis of 483 issues & inspection outcomes

Related tags: Dietary supplement

Preliminary data from 2015 presented at a recent industry forum indicate that the Food and Drug Administration is issuing fewer 483s and the issues generating these observations during inspections are shifting from identity testing to specifications. The shift was seen as generally supporting the notion the industry GMP compliance is improving.

Recent FDA figures

Two sessions as the recent Rocky Mountain Dietary Supplement Forum focused in part on the recent results of FDA’s inspections of dietary supplement firms. Corey Hilmas, senior vice president of scientific and regulatory affairs for the Natural Products Association and a recent employee of the agency, touched on the subject during his industry overview session and several officials from the Denver FDA office also offered their perspective. Also in attendance was Moab, UT-based consultant Marion Boardley, who for several years has offered her independent analysis of where the industry is headed based on the relative numbers of various 483 citations that crop up during inspections.

Boardley, who is a stickler for statistical accuracy, predicated her comments with the caveat that FDA is set to release more complete statistics in the next month or so. But she was able to do an initial analysis based on information made available at the meeting, which took place near the end of September in Boulder, CO.

“Based on the preliminary data, it shows that the overall focus has shifted from identity testing (or the lack thereof) toward specifications. Over the years, 483s concerning identity testing was the focus. At first they were just happy if companies had specifications. But I think now there a number of examples of FDA looking at specifications more deeply,” ​Boardley told NutraIngredients-USA.  

Boardley said in the initial go-round for GMP inspections, FDA focused on some very basic failures, especially among the smallest tier of companies that were required to be in compliance starting in 2010.  Companies were all too often cited for lacking a robust scheme for verifying the identity of incoming raw materials, either using tests that were not fit for purpose or doing no tests at all and relying on Certificates of Analysis on incoming lots as identity verification.

Companies seem to be getting that word, Boardley said, so the agency is shifting to the next level of complexity and looking at specifications with regard to how carefully these are written and the procedures for verifying whether the products a company actually produces meet these specifications.

“I think there are definite signs that things are improving,” ​Boardley said.

To bolster her claim that the industry is getting better, Boardley supplied NutraIngredients-USA with her compilation of figures through 2014. The number of No Action Indicated (NAI) inspections have been steadily rising, while the number of Voluntary Action Indicated (VAI) inspections plunged for the first time after rising steeply for the years since the smallest tier of dietary supplement companies were brought into the GMP fold in 2010. There were 279 NAIs and 229 VAIs in 2014.  Those figures in 2013 were 319 VAIs and 216 NAIs.  The number of inspections that fell into the most serious category, the Official Action Indicated (OAI) inspections, also fell, from 87 in 2013 to 34 in 2014.

Hilmas said the figures are an indication in part that the biggest companies, those that have had to be in compliance since 2008, and the mid sized companies, on board since 2009, are now achieving more seamless compliance. 

True progress, or statistical quirk?

“The largest firms are getting it; they are investing in GMP compliance whereas three years ago they weren’t,”​ Hilmas said.

Boardley said that the figures are potentially skewed by the significant number of re-inspections that are starting to filter through the system and show up in the overall tallies.

“The problem we have is that there are a lot of re-inspections going on. FDA is pretty much going back in within a year or two of the initial inspections and doing another. At the same time the number of OAI inspections is really going down compared to what it was and the number of NAI inspections is going up,​” she said.

Boardley said that this also could be an indication of rising quality assurance competence within the industry rather than a quirk of FDA hoeing the same ground again in some cases. Some VAI inspections might have been classified as OAIs in earlier years, but as companies take more steps toward compliance including hiring the right personnel or investing in the proper training, the agency has more confidence that they can pull the needed changes off.

“If you have a VAI inspection, one in which you received a 483, you know that FDA found some holes but it considered your quality assurance is good enough to fix those things without having to be publicly humiliated with a warning letter,” ​Boardley said.

Forum information

For more information the forum, which was hosted by Boulder, CA-based consulting firm FDA Compliance Group LLC, click here​.

Related topics: Regulation, GMPs, QA & QC, Adulteration

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