An investigation into the Food and Drug Administration’s drug approval and manufacturing oversight process has raised questions about whether the agency’s reliance on limited inspections and self-reported manufacturer data leaves gaps that put patients at risk, particularly for drugs made at overseas facilities.

The FDA has faced longstanding criticism over its capacity to inspect the growing share of drug manufacturing that occurs outside the United States, with critics arguing that inspection frequency and rigor have not kept pace with the globalization of pharmaceutical production.

FDA officials have defended the agency’s inspection regime as risk-based and consistent with international standards, while acknowledging resource constraints.