FDA issues warning letters to manufacturers over CGMP and GLP violations

The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems ensuring that final products are sterile and conform to established specifications.

A research laboratory also received a warning letter for not complying with good laboratory practice standards, specifically for insufficient detail in the final report describing the experience of animal subjects used in studies.

In a related commentary, former FDA commissioner Scott Gottlieb and other experts called for a dedicated regulatory framework for clinical AI models used in academic medical centers, arguing they should not be treated as commercial medical devices nor left unregulated.