We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Since 2016, the facility launched a “substantial number” of OOS investigations for multiple drug products but frequently closed them without finding a root cause, the agency said.
Read More
An Eli Lilly facility in Puerto Rico drew the FDA’s attention for manufacturing and quality deficiencies related to its breast cancer treatment abemaciclib. Read More
Five drugmakers were cited in FDA inspections for violations that ranged from inadequate smoke studies to a “cascade of failure” at one facility. Read More
Novartis subsidiary AveXis placed the blame for data manipulation over its $2 million spinal muscular atrophy drug Zolgensma squarely on two former senior executives, in a lengthy response to the FDA’s Form 483 inspection observations. Read More
The FDA hit three overseas drugmakers for violations at their facilities that included testing deficiencies, a lack of cleaning validation and other slipups. Read More
The FDA issued a warning letter to NuCare Pharmaceuticals in Orange, California for failing to fix drug listing deficiencies in the agency’s database. Read More
Texas drugmaker Isotherapeutics was hit with a Form 483 for multiple violations at its Angleton facility, including problems with its cleanrooms. Read More