FDA Issues Form 483 to Sun Pharma for Mfg Violations

The US Food and Drug Administration (FDA) has issued a Form 483 with four observations to Sun Pharmaceutical Industries following a pre-approval inspection of the company’s facility in Halol, Gujarat, India, which was from June 3, 2019 to June 11, 2019.

A Form 483 notifies the company’s management of objectionable conditions at a facility found by the FDA.

Sun Pharma says it will be submitting its response to the observations to the FDA within 15 business days of receipt of the Form 483, which was received on June 11, 2019. Sun Pharma says it “is committed to addressing these observations promptly.”

Sun Pharma says there is no material impact of these observations on the company.

Source: Sun Pharmaceutical Industries

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