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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Resiliency Roadmap Update: US FDA Exceeds FY 2021 Inspection Projections
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.
The Quality Lowdown: Enforcement And Compliance During A Lingering Pandemic
US FDA oversees plants straining to meet demand for COVID-19 vaccines and treatments, while cracking down on adulterated hand sanitizers.
The Quality Lowdown: The Warning Letter Monsoons That Might Follow The Inspection Drought
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.