FDA Enforcement Initiatives Raise Visibility Of Supply Chain GMP Issues
US FDA is issuing “90-day” decisional letters at a quickening pace, publishing the inspectional results within another 30 days, and copying sponsors on warning letters, among other steps, to call their attention to GMP problems in their supply chains.
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Happy New Year – or not! Firms inspected by US FDA since Oct. 1 will receive word within 90 days whether their facilities received passing – or failing – grades under timelines mandated by GDUFA II and incorporated into the agency's new Concept of Operations agreement, FDA officials tell FDLI meeting.
Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.
Agency officials advise drug supply chain partners what stabilization activities they expect to see during one-year “enforcement discretion” period; industry lawyers advise that anyone found coasting could face discretionary enforcement. More discretion, more guidance in the works, including a final ruling on state preemption.