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January 8, 2024
The top five dietary supplement manufacturing violations cited last year by the Food and Drug Administration relate to quality control (QC), written procedures and establishing specifications, Natural Products Insider has learned.
Based on FDA inspections of facilities in FY23, the most common “observation” or violation of the cGMPs (current good manufacturing practices) 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.
Of the facilities that received a so-called Form 483, nearly 33% (78 inspections) were cited for this violation, according to FDA data obtained through a Freedom of Information Act (FOIA) request. FDA issues a Form 483 following an inspection when an investigator has observed any conditions that he believes may violate the Federal Food, Drug & Cosmetic Act (FDCA) and related acts, according to an FDA webpage.
The second top cGMP violation was based on 21 CFR 170(b)(2), which requires manufacturers establish component specifications to ensure specs for the purity, strength and composition of the dietary supplements are met. Roughly 20% of firms (47 inspections) who received a 483 were cited for this violation, the FDA data showed.
Rounding out the top three cGMP violations in FY23: not meeting the requirement to establish an identity specification in 21 CFR 170(b)(1), with about 18% of firms (43 inspections) getting cited.
The fourth most common cGMP infraction (17.5% of inspections with 483s) is based on the requirement in 21 CFR 111.103 to establish and follow written procedures for the responsibilities of the QC operations. That was followed by violations regarding the rule in 21 CFR 111.453 to establish and follow written procedures for holding and distributing operations (17.1% of firms or 41 inspections with a 483 received this citation), FDA data showed.
Of the 501 total domestic and foreign inspections in FY23, 48% of firms were issued a 483, FDA data showed. Of the 40 foreign inspections in 17 countries, 24—or 60%—were issued a 483, according to the FDA data. And of those firms that received a 483, firms were cited with an average of about five cGMP observations, the FDA data showed.
According to FDA, a Form 483 does not necessarily constitute an all-inclusive list of every possible infraction of the law and FDA regulations.
“The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection,” FDA explains on the webpage referenced above. “There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection.”
Fifty two percent of supplement firms inspected by FDA (261 inspections) were not cited for any cGMP violations.
The data above reflects observations queried from an FDA inspection database and may exclude some manually prepared 483s.
FDA typically conducts 500 to 600 annual cGMP inspections, according to Cara Welch, director of FDA’s Office of Dietary Supplement Programs (ODSP).
“Facility inspections play an important role in FDA’s oversight of dietary supplements, providing a snapshot of a firm’s compliance with the regulatory requirements,” Lindsay Haake, an FDA spokeswoman, said in an email.
She underscored the importance that specifications play in the cGMPs to ensure products are made according to quality standards.
“The current good manufacturing practice … requirements in 21 CFR 111 are integral in ensuring a quality dietary supplement marketplace by building quality into the product throughout the manufacturing process,” Haake added. “This begins with quality starting materials and continues with the product being manufactured in a reproducible manner according to established specifications. Therefore, having established specifications for the components and finished products is fundamental to building a quality product.”
Dean Cirotta is president of EAS Consulting Group. He and his firm are experts on FDA regulatory matters including cGMP compliance. Cirotta has been examining FDA cGMP inspectional data for well over a decade.
Before being interviewed for this story, Cirotta reviewed a 2014 presentation he gave, in which he referenced FDA FY13 data. Most of the top cGMP violations cited by FDA a decade ago, he observed, are the same ones that FDA reported in FY23.
“Unfortunately, it doesn’t seem like anything is really changing,” he said in an interview. “The industry is still struggling with the same things.”
For instance, he cited the requirements to appropriately test dietary supplement products and ensure they meet specifications and establish proper documentation procedures.
Cirotta said he doesn’t believe the top cGMP violations found over the years are related to “FDA bias.” Instead, he feels the industry is struggling with the same cGMP issues, “and it’s the things that are most expensive and most difficult with GMP compliance: specs, testing, documentation.”
Why are many manufacturers of supplements still falling short of fundamental cGMP requirements?
“The smaller companies normally don’t have people who are qualified to do it,” Cirotta responded. “They don’t understand the regulations. They don’t have the background and the experience in quality.”
Working to ensure cGMPs are compliant with the FDA regulations, he added, is not a job for one individual.
“It’s just impossible for one person to maintain a company’s compliance,” he noted in a follow-up email. “Compliance with the regulations is very expensive.”
For instance, he pointed to costs related to establishing specs for components and finished products, and regularly testing those products according to the regulations.
“Unfortunately, it seems that nothing has changed in 10 years,” Cirotta concluded, referencing the same top citations compared to a decade ago. If FDA “wants to change this, there needs to be continued and increased enforcement … in these areas, and increased investment in personnel and resources by the industry because it’s the same theme we saw 10 years ago.”
Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition
Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a special focus on regulatory issues, including at the Food and Drug Administration.
Josh majored in journalism and graduated from Arizona State University the same year ‘Jake the Snake’ Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.
Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
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