Four out of ten dietary supplement firms inspected last year by FDA that were cited for violations of manufacturing rules ran afoul of requirements to set product specifications or failed to adequately establish such specs, Natural Products Insider has learned.
Of the firms that received a Form 483 for violations of the federal rules, 59 inspections—or about 40%—were cited for failing to establish product specifications for identity, purity, strength and composition of the supplement’s finished batch.
FDA may note such a violation of the cGMP (current good manufacturing practice) requirements “when the firm has not established any specifications or when the specifications are inadequate,” Lindsay Haake, an FDA spokeswoman, explained.
In FY21, three of the top five cGMP violations related to specifications, FDA data showed. Natural Products Insider obtained the data through a Freedom of Information Act (FOIA) request.
Asked to explain the importance of manufacturers setting specs for such traits as identity, strength and composition, Haake responded, “A dietary supplement manufacturer must have controls in place to help ensure the product contains what is purports to contain and consistency across products.”
Other common cGMP violations related to requirements to establish and follow written procedures for quality control (QC) operations and product complaints.
As Natural Products Insider previously reported, FDA in FY21 performed fewer than 300 inspections of dietary supplement facilities to assess their compliance with manufacturing rules.
In the fiscal year ending Sept. 30, 2021, FDA conducted 278 cGMP inspections, with the majority (275) focused on U.S. facilities. That compares to 289 inspections the previous year, when the COVID-19 pandemic emerged, FDA data show.
“Facility inspections are a snapshot of a firm’s compliance with the regulatory requirements, but even with fewer inspections this year, these inspections are still valuable to how the agency regulates dietary supplements,” Haake said.
Of the 278 inspections in FY21, 147—or 53%—received a Form 483. The other inspections—131, or 47%—were not cited for any cGMP violations.
Perhaps equally or more encouraging, few firms inspected that received a final classification fell into an FDA category recommending regulatory action, such as a warning letter or injunction.
Of the 203 inspections that received a final regulatory classification based on FDA’s response to the FOIA request, only three inspections were classified “official action indicated.” Ninety six inspections were classified voluntary action indicated, and 104 were classified no action indicated.
Still, FDA signaled there remains ample room for improvement among the dietary supplement industry in meeting manufacturing rules adopted in 2007.
The cGMP “requirements are integral to a safe and high-quality dietary supplement marketplace,” Haake shared in a Dec. 10 email. “That said, notwithstanding the efforts of a number of firms who take compliance very seriously, the fundamental deficiencies being identified remain concerning. For example, establishing finished product specifications and written procedures for quality control personnel remain the two most-cited violations again this year, both of which are integral to an effective cGMP system.”