Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.
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While better than one its ‘best case’ scenarios, FDA has completed just 31% of 15,514 domestic surveillance inspections planned for FY 2021, applications are still being delayed, and foreign inspections have for the most part yet to be tackled.
US FDA oversees plants straining to meet demand for COVID-19 vaccines and treatments, while cracking down on adulterated hand sanitizers.
Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.