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

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,

“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.

Sep 11, 2018

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