The Quality Lowdown: Problems At Iso-Tex, Centaur, Biocon, Lupin And US Specialty
Hot, humid clean rooms, drug-caked equipment, stuck syringes, iffy contraceptives and iffy GMPs were among the pharmaceutical quality shortcomings that surfaced recently.
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One in five of the drug GMP warning letters the US FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became a major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. The year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier, and the other a unit of DuPont.
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
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.