Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable
Executive Summary
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.
You may also be interested in...
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.
Merck’s COVID Manufacturing Deal With US Government Goes Well Beyond J&J Vaccine
‘Wartime’ contract with BARDA will fund up to $268.8m in production site upgrades so Merck can also produce other COVID-19 vaccines and therapeutics as needed.