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.
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Agency will provide guidance in wake of recent outbreaks of Burkholderia cepacia in non-sterile, water-based drug products.
Quality and the measure of a firm: Toyobo’s particulates and resins, Galenicko’s sanitation, Breckenridge’s product chemistry and Fujifilm’s cross-contamination risk.
Sanit Technologies must provide FDA with full reconciliation for all hand sanitizers not recalled and detailed plan of business closing. Warning letter notes its product’s risk to vulnerable populations and its distribution to schools with young children.