Cadila manufacturing facility in India gets FDA Form 483 for 5 observations

Cadila's Liva subsidiary was hit with a Form 483 by the FDA following an inspection of its plant in Vadodara, India. (FDA)

Liva Pharmaceuticals, a wholly owned manufacturing facility of Indian drugmaker Cadila Healthcare, was hit with a Form 483 (PDF) by the FDA following an inspection of its plant in Vadodara, India.

Regulatory inspectors visited the injectables plant from Aug. 20-28, during which they cited the company for five observations. Issues at the facility included problems with Liva’s product sterility procedures, deficiencies in monitoring environmental conditions, lack of proper training for employees and problems with its record keeping process.

In the Form 483, the agency said inspectors found “containers having obvious breach of container/closure integrity such as cracked container, broken container, containers with missing stopper/closures” that had not been rejected or discarded with appropriate documentation,

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

“This was a product specific preapproval inspection,” the company said in a filing with the Bombay Stock Exchange. “It concluded with five observations. Liva will respond to the USFDA with 15 days.”

The company added that the Liva facility does not currently export any products to the U.S. market.