FDA Prioritizing GMP Re-Inspections for High-Risk Dietary Supplement Firms

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FDA Prioritizing GMP Re-Inspections for High-Risk Dietary Supplement Firms

This article was sparked from reading Josh Long’s post on Insider Law about inspections of Dietary Supplement firms for compliance with Good Manufacturing Practices (GMPs). These firms had previously failed an inspection and were targeted by the FDA as “high-risk”, thus precipitating the need for re-inspection.

Josh reports that half of the dietary supplement companies that were re-inspected last year, were flagged as being “significantly noncompliant with cGMPs” after previous inspections.

63 companies were rechecked for compliance. 32 of these firms had previous been a subject of “official action indicated (OAI)”. An OAI is a status of an Establishment Investigation Report (EIR) that is issued by an investigator that comes with a Form 483¹. A Form 483 is a form number used by an FDA investigator that is conducting an investigation that documents their findings. Thus, after the investigation, sanctions may be forthcoming due to what was found. The next step is a Warning Letter. OAI is the most serious status of the EIR statuses, the others being “No Action Indicated (NAI)” and “Voluntary Action Indicated “VAI”. Firms must respond to these reports and are given top priority for re-inspections.

44% of the 32 re-inspected firms in 2015 were cited by the FDA for failure to verify the identity of a dietary ingredients prior to its addition in manufacturing through an appropriate test or exam. This means that these firms failed to create a Specification for an ingredient through appropriate tests, methods and acceptance limits. An example of an improper test could be using visual verification for the purity of a raw material. Specifications are a huge proponent of complying with Good Manufacturing Practices (GMPs) and a cornerstone of InstantGMP’s software.

34% of firms were cited for incomplete Batch Production Records and 31% neglected to establish Specifications period in past inspections.

Re-inspection data has shown improvements by companies. 7 of the 32 facilities were cited for failing to verify the identity of an ingredient a second time.

In a larger scope of the situation, testing materials continued to be the most common violation found during re-inspections that have the OAI status. Dr. Dan Fabricant, executive director and CEO of the National Products Association (NPA), noted that companies seem to think the FDA won’t come knocking again to make sure the issue is resolved.

Insiders previously reported that the FDA inspected 500 firms for compliance with cGMPs in 2015, but that’s only a tiny fraction of the more than 13,000 dietary supplement firms registered with the FDA. Michael McGuffin, president of the American Herbal Products Association (AHPA), commented that the FDA will never have the resources necessary to inspect the firms as much as it would like to; therefore, it must be judicious about its resource allocation. He does agree that going after the firms that were issued an OAI was probably the best use of the agency’s limited resources.

What Exactly Are cGMPs?

Current Good Manufacturing Practices (cGMPs) were adopted in 2007. Small companies have been required to comply starting in 2010. GMPs are common sense rules, with the priority being consistency during manufacturing, but they have a very large technical aspect as well.

cGMPs require manufacturers to prepare and follow Master Manufacturing Records (MMR) aka Master Production Records (MPR) or Master Batch Records (MBR) during production. The documentation that needs to be generated when making a batch is a Batch Production Record (BPR). This is a record that verifies a specific batch followed the recipe in the MMR to the letter.

A large number of firms fail to provide the FDA with adequate documentation about how their batches are made, and the FDA penalizes them for it. Steve Mister, president and CEO of the Council for Responsible Nutrition, mentioned that companies don’t understand what they need to do. They are either “burying their heads in the sand” or have no idea what the requirements are asking them to do.

For the most part, there’s a shortage of information about cGMP requirements that are available in terms that laymen can understand.

Though the FDA is quite serious about bringing firms into compliance, their largest criticism has been about bringing action to noncompliant firms. Some perceive the FDA as an agency that cuts these firms’ breaks if they’re trying to comply or show an earnest desire to start on the path to compliance. It’s also true that having injunctions issued, court actions made, and seizure of products are time and resource-intensive processes.

Dr. Pieter Cohen talks about how if there were an industry-wide set of Standard Operating Procedures, firms would know that in order to put their products for sale, they’d need to establish Specifications and issue Batch Production Records. The absence of a production “checklist” allows for companies to slip under the radar, but if there was a publicized checklist, companies would initially follow cGMP requirements and the rate of citations would fall.

The other issue is that while the Food Safety Modernization Act (FSMA) granted the FDA the power to conduct mandatory recalls, it must indicate that products that are adulterated must pose a serious risk of adverse reaction or death. The industry is fine with the FDA being granted more abilities to stop these noncompliant firms instead of re-inspecting them and issuing Warning Letters ad nauseam.

Coming into compliance can be costly, and the requirements can be difficult to navigate if you’re unfamiliar with GMPs.  While there is no industry-wide set of Standard Operating Procedures, InstantGMP provides a set that does help companies meet cGMP requirements. InstantGMP™ MES was developed by pharmaceutical industry veterans to help manufacturers of Dietary Supplements, CBD, and Medical Marijuana come into compliance with GMPs through the use of Electronic Batch Records and is an invaluable solution when needing to pass an audit or inspection by the FDA. These solutions are cost-effective for every sized firm as compared to other software or consultants. We invite you to sign up for a personalized demo where we’ll show you how InstantGMP™ MES can integrate with your current process.


¹Source: FDA Inspection Reports: What is what?