CDER’s Office of Compliance highlights enforcement actions in 2023

The Office of Compliance (OC) in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) said preventing diethylene glycol (DEG) or ethylene glycol (EG) contamination, curbing distribution of potentially dangerous ophthalmic products, and working towards implementation of the Drug Supply Chain Security Act were among its top priorities in 2023.

FDA also observed an increase in warning letters citing a failure to respond to a request for written records under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The office’s FY 2023 annual report also outlined some of the agency’s enforcement activities for the year and provided a glimpse into some of the top violations cited in warning letters to drugmakers. Current good manufacturing practice (45%), unapproved new drug/misbranding (22%), and refusal to provide access to and copying of records (7%) were the top violations cited in warning letters last year.

Office of Compliance Director Jill Furman highlighted some of these enforcement priorities. She said that “new public health challenges emerged in 2023, requiring careful attention and swift action to protect consumers. We pivoted to preventing and addressing contamination from diethylene glycol and ethylene glycol (DEG/EG), harmful and potentially harmful eye products, and mitigating risks from drug shortages while ensuring the safety our drug supply.”

OC issued 170 requests for information to manufacturers requesting documentation confirming they were testing their products for DEG and EG and issued warning letters to those that failed to respond. To promote compliance, FDA clarified testing requirements in an immediately-in-effect guidance on DEG testing. (RELATED: Amid DEG/EG contamination concerns, FDA issues guidance on testing high-risk drug components, Regulatory Focus 10 May 2023).

Other priorities were to curb distribution of “potentially dangerous” ophthalmic products. “Ophthalmic drug products are especially concerning from a public health perspective because products intended for use in the eyes generally pose a greater risk of harm due to the route of administration that bypasses some of the body’s natural defenses,” said Furman.

Over the past year, OC recommended recalls, issued warning letters to companies to flagged for insanitary conditions and GMP violations, and warned the public regarding unapproved eye products and potentially contaminated eye drops.

Another priority was to give trading partners additional time to implement, troubleshoot and mature their systems in anticipation of DSCSA, which goes into effect next November. “We heard concerns about supply chain readiness related to implementation of the Drug Safety Supply Chain Act (DSCSA) and we believe that some flexibility will support successful implementation and lead to a stronger and safer drug supply chain,” said Furman.

FDA issued a guidance in August 2023 granting trading partners an additional year to get these enhanced drug distribution security systems up and running. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)

Furman said that “compared to last year, we saw an increase in warning letters citing a failure to respond to FDA-issued requests for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”

The top GMP violations in FY 2023 warning letters were for deficient quality control units under 21 CFR 211.22, a problem found in 48 letters. The next highest area was inadequate control and testing of components, containers, and closures under 21 CFR 211.84, which were cited in 47 letters. This was followed by deviations from written procedures under 21 CFR 211.100, found in 30 warning letters, followed by production record review under 21 CFR 211.192 found in 16 warning letters, and equipment cleaning and maintenance lapses under 21 CFR 211.67(b), found in nine warning letters. FDA noted that this breakdown excludes warning letters sent to compounding facilities.

In addition, most of the GMP warning letters, 45%, were based on an FDA reinspection, 28% were based on remote oversight tools, 22% were from a first inspection of a facility and 5% from FDA testing products at the border.

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CDER’s Office of Compliance highlights enforcement actions in 2023

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