In Food and Drug Law Institute Update, Washington, D.C. Attorneys Analyze COVID-19 Impact on CGMP Compliance Enforcement and FDA Warning Letters

An article in Food and Drug Law Institute Update by life sciences regulatory & compliance partner Joshua Oyster and associate Rebecca Williams (both of Washington, D.C.), reviewed the impact of COVID-19 on the U.S. Food and Drug Administration’s ability to monitor and enforce current good manufacturing practice compliance (CGMP) and analyzed the resulting shift in manufacturing-related warning letters based on FDA’s alternative tools and other recent trends.

The authors conclude that FDA’s use of sample testing and records requests has been integral to the agency’s efforts to ensure continued CGMP compliance and product quality during a time when the agency’s ability to conduct inspections has been limited.