FDA officials are offering mixed views on overseas inspection strategies, particularly for biologics and biosimilars, with some calling for enhanced inspections of all foreign facilities and others saying risk-based reviews work well abroad.
While the FDA’s overseas inspection rate has improved in recent years, the agency still inspects “relatively few” foreign facilities compared to domestic sites, and most inspections continue to be unannounced, government auditors said in a new report Sept. 14.
FDA inspectors continue to see systemic GMP problems in their overseas inspections, and greater drugmaker oversight of foreign partners — such as on-site compliance officers — may be warranted, FDA officials say.
The contaminated heparin crisis from years back “could still be happening” and the FDA continues to focus some of its limited resources on keeping the fake anticoagulant out of the U.S. drug supply, the FDA says.
The recent spike in shortages of medically necessary drugs is more likely to be resolved by taking many small steps than a few big ones, according to dozens of representatives from patient, provider and drug industry groups who met Sept. 26 at an FDA forum on the subject.
An FDA warning letter to Deibel Laboratories citing current cGMP violations “shocked” the company, but showed Deibel it needs to better understand its clients, the contract testing organization’s chief told DGR Sept. 15.
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