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.

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.

Hot, humid clean rooms, drug-caked equipment, stuck syringes, iffy contraceptives and iffy GMPs were among the pharmaceutical quality shortcomings that surfaced recently.

Sterile drug manufacturers get one year to comply with most revisions in updated EU, PIC/S and WHO GMP Annex 1 guideline. PDA survey hints at scale of challenge facing firms that still use traditional open filling lines, a practice expected to end under the Annex 1 revisions.

Potential distribution hitches could spark shortages of legitimate drugs if the system is not fully ready for package-level tracing requirements, US FDA says in delaying enforcement of the program a decade in the making. Poll shows supply chain partners were making significant progress in preparing for the 27 November deadline.