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The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
The FDA is warning healthcare providers and patients not to use sterile drugs made by an Oklahoma compounder after the firm refused to cease sterile operations following a failed inspection — the latest in a stream of safety alerts, warning letters and Form 483s having to do with compounders’ sterility practices over the past year. Read More
Merck is recalling thousands of bottles of Temodar and temozolomide capsules because cracks in the caps have rendered the child-resistant closure ineffective. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
The FDA’s new proposed team-based inspection program completed initial inspections in its ongoing pilot and was deemed a huge success that helped investigators plan better inspections. Read More
An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds after the FDA received reports of adverse events. Read More
Indian drugmakers are once again under scrutiny as the FDA issues warning letters and import alerts to India’s Pan Drugs Limited, Sipra Labs and Polydrug Laboratories. Read More