FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
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FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements.
The letters point to issues such as ensuring final product sterility and adherence to specifications.
A research laboratory also received a warning for violating good laboratory practice (GLP), specifically for insufficient detail in reporting animal study experiences.
The notices underscore heightened regulatory oversight of manufacturing and research processes.
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This writeup was produced by pharmadog from original reporting by raps.
Original headline: “This Week at FDA: HHS staff assessments raise concerns, former FDA chiefs criticize DOGE, and more”
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