You are using an older browser version. Please use a supported version for the best MSN experience.

Lupin’s Goa facility clears US FDA inspection

LiveMint logoLiveMint 21-07-2017 Isha Trivedi

Mumbai: Lupin Ltd said on Friday that its Goa manufacturing facility has cleared a pre-approval inspection (PAI) conducted by the US Food and Drug Administration (FDA) between 17 July and 21 July.

A pre-approval inspection (PAI) is product specific. It is performed to contribute to US FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing the drug, and that submitted data are accurate and complete.

The US regulator did not make any observations related to deviations from quality norms during the inspection, Lupin said in a stock exchange filing.

However, the Form 483 issued to Goa site post US FDA’s audit during 27 March-7 April is not yet cleared.

During the March audit, the US FDA had observed that the firm failed to thoroughly review any unexplained discrepancy or out of specification batches, it did not have written procedures for production and process control and it had not established control procedures to monitor the causes of variability in characteristics of in-process material and drug product.

The FDA issues a Form 483 to a company’s manufacturing unit if its investigators spot any condition that in their judgement may constitute a violation of the US Food Drug and Cosmetic (FD&C) Act and related acts.

Lupin’s unit-II and unit-III at Pithampur in Madhya Pradesh have also been issued a Form 483 by the US drug regulator.

On Friday, shares of the company ended down 2% at Rs1,142.85 on the BSE, while the benchmark Sensex index closed up 0.4% at 32,028.89 points.

More From LiveMint

image beaconimage beaconimage beacon