FDA’s drug quality report card details enforcement trends, increased inspections in 2022
In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) cited an increase in the number of non-compliant drug samples tested in FY 2022 compared with recent years and noted a growing number of recalls. It also found that the number of surveillance inspections “nearly tripled” in 2022 in a shift toward pre-COVID-19 levels.The report is the fifth annual State of Pharmaceutical Quality report from OPQ, and it presents key data that characterize drug and manufacturing site quality. This includes data from inspections, product quality defects, import alerts and recalls.
Growth in manufacturing sites
FDA’s site catalogue reflected 4,814 drug manufacturing sites, a 12% increase over FY 2018. The number excludes manufacturers that only produced alcohol-based hand sanitizers during the COVID-19 public health emergency (PHE). Forty percent of these sites are in the “No Application” sector, meaning that products manufactured at these sites can be marketed in the US without approved FDA applications.
Most of these manufacturing sites are located outside of the US. In a post to FDA’s website, OPQ Director Michael Kopcha noted that “While 90% of the 227 drug and biological products deemed to be essential medicines have at least one manufacturer in the U.S., most active pharmaceutical ingredients are made solely by foreign manufacturers.”
The US, Canada, China, France, Germany, India, South Korea and Switzerland all saw double digit increases in the number of registered manufacturing sites in FDA’s site catalog over the past five years, while Italy and Japan saw slight decreases.
Increase in non-compliant samples
In FY 2022, the number of non-compliant drug samples increased to 57.5%, or 892 of 1,552 samples tested. This is an increase from the 35% that failed sample testing in FY 2021; while the non-compliance rate was 16% in FY 2020. (RELATED: OPQ’s FY2021 report gives mixed review on state of drug quality, Regulatory Focus 30 August 2022)
The imports-based testing program found that most of the noncompliant samples, 592, were from drugs that contained undeclared drugs or ingredients shipped in small quantities directly to consumers. The testing program also focused on products related to the COVID-19 public health emergency and found 228 of the noncompliant samples were all for hand sanitizer products that lacked potency or had unacceptable levels of impurities.
Sampling and testing are methods of inspections used when FDA cannot get to sites to conduct inspections.
Growing number of recalls
The number of recalls increased to 912 in FY 2022, the highest number in five years, increasing steadily from 700 in FY 2020 to 800 in FY 2021.
“As in prior years, the largest defect group for recalls continued to be CGMP deviations,” the report states. In FY 2022, most of the recalls (465) were attributed to GMP violations, followed by 135 recalls attributed to temperature excursions, 116 for failing specifications, 57 recalls tied to product defects and eight recalls due to packaging problems.
Most of the recalls were for drugs intended to treat the respiratory tract, followed by cardiovascular agents, analgesics, antibacterials and gastrointestinal agents.
Tripling of surveillance inspections
In other areas, FDA said the number of surveillance inspections “nearly tripled” in 2022, although the OPQ director said that “travel restrictions … continued to pose challenges.”
FDA conducted 328 surveillance inspections, 129 inspection classifications under Mutual Recognition Agreements (MRAs) and 49 surveillance systems-based assessments using information from 704(a)(4) requests.
“The number of surveillance inspections was nearly triple the amount (115 inspections) accomplished in FY 2021, demonstrating progress in returning to pre-PHE inspection levels,” the report states.
Report, OPQ director’s message
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