FDA Representative Predicts More Onsite Inspections, Reveals Current Warning Letter Trends
October 10th, 2024 // 2:27 pm @ jmpickett
According to an official from the Center of Drug Evaluation and Research (CDER), the FDA’s manufacturing quality staff focuses on two areas: stopping diethylene glycol (DEG) or ethylene glycol (EG) contaminants from entering pharmaceuticals and ensuring that companies making ophthalmic drugs correctly test sterile products.
Francis Godwin, director of the Office of Manufacturing Quality at CDER, talked about compliance trends in a recent interview with an industry magazine. He pointed out the importance of drug companies designing a quality culture, as well as talked about drug quality problems that concern him in 2024.
Goodwin said that top priorities for CDER on 2024 are focusing largely on diethylene glycol and ophthalmic products. The 2023 FDA annual report talked about several outbreaks abroad and the agency’s greater concern about supply chain controls. This year, many of the warning letters FDA is sending are preemptive efforts to ensure drug companies have the proper controls in place to stop diethylene glycol in products from getting into our supply chain.
The CDER official added that ophthalmic products is another area where FDA has more concern and priority. This is largely because these products must be sterile. If they aren’t high quality, they can be hazardous to US consumers. Many of these drug products are sold over the counter and don’t go through the premarket review process.
Goodwin also discussed the FDA’s shift to on-site inspections in 2024. He noted that during the pandemic, the FDA had travel restrictions in place. Onsite inspections continued, but there were fewer of them. Now, the FDA is going back to on-site inspections in 2024 and beyond. As of August 2024, almost 80% of CDER warning letters issued were for drug adulteration, based on on-site audits.
Also, going back to 2019, all warning letters issued by CDER were based on onsite inspections. During the COVID pandemic, warning letters were delivered based on record requests and other alternative tools. Most inspections now are onsite, but about 25% are done by sampling or electronic records.
He noted that while data integrity is important in drug manufacturing, the subject isn’t a major source of warning letters currently. About 17% of warning letters from 2024 had issues with data integrity. However, data matters, and if there is a serious problem with integrity at a drug facility, all of the data quality at that plant is called into doubt.
Goodwin said that 86% of drug GMP warning letters issued as of August 2024 for the year were issued to OTC manufacturers, or what he called non-application drugs. There isn’t any premarket review, and is related to drug manufacturing globalization and non-application drugs. Many of the warning letters relate to where a manufacturer making industrial products sees a need for a drug over the counter. They say they will start making it, ship it to the USA, but they don’t know there are specific requirements for making drugs in the US.
