FDA Update

Assuring the Quality of Medicines is Not So Plain and Simple

Report on the State of Pharmaceutical Quality

The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. This mission is not easy, but it is critically important. As our new Fiscal Year 2022 Report on the State of Pharmaceutical Quality explains, CDER’s catalog includes more than 4,800 manufacturing sites around the world making more than 140,000 drug products for U.S. patients and consumers.

Quality is complex, involving the process, facility, and supply chain. There is no single tool that can assure quality, but a combination of complementary tools can make it more feasible to surveil the U.S. pharmaceutical market.

• FDA samples and tests potentially noncompliant products using appropriate and validated testing methods to avoid erroneous findings. This strategy that was effective in identifying 892 noncompliant samples in 2022, most of which were imported. We also analyze product quality defects, including those reported through field alert reports which decreased by 15% in 2022.
• Surveillance inspections nearly tripled in 2022, though travel restrictions continued to pose challenges. Fortunately, remote regulatory assessments of facilities were made possible by tools such as records requests and mutual recognition agreements with other trusted global regulators.
• When there were significant problems with any product or facility, CDER acted by creating import alerts, handling product recalls, and issuing warning letters to facilities, which we did more than 1,000 times in 2022.

The FDA is back going out and conduction on-site inspections. The number of 483 observations and the issuance of warning letters are increasing as the companies are not prepared for these visits after the long covid virtual inspection.  Companies should know that the FDA inspections are detailed and being prepared in understanding how the FDA conducts inspections and what to expect of an FDA visit could help in preventing regulatory actions.

Questions?

If you would like to discuss and FDA regulatory issue or how do deal with the FDA inspection, or respond to a 483 or W/L please feel free to contact us at:

at: info@mdiconsultants.com and ref: pharmaceutical quality.