USFDA issues Form 483 for 6 observations to Jubilant Pharmova

The company will submit an action plan on the observations and will engage with USFDA for next steps.

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USFDA Form 483

Last Updated on August 5, 2022 by The Health Master

The US Food and Drug Administration (USFDA) recently completed an audit of the Solid Dosage Formulations facility at Roorkee, India, of Jubilant Generics, a subsidiary of its wholly owned subsidiary Jubilant Pharma Limited, according to Jubilant Pharmova Limited in Noida.

The USFDA has issued six observations on Form 483 pursuant to the completion of the audit.

“The company will submit an action plan on the observations and will engage with USFDA for next steps,” the company stated in its recent release.

Jubilant Pharmova Limited (JPM) had previously been reported as having received an import alert from the US Food and Drug Administration (USFDA) during the agency’s inspection of the Roorkee dosage formulations facility.

A company called Jubilant Pharmova Limited works in the pharmaceutical, contract research and development, and proprietary novel drug industries.

Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in the manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Therapy Products, Contract Manufacturing of Sterile Injectibles and Non-sterile products, APIs, and generics through six USFDA approved manufacturing facilities in the US, Canada, and India.

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