Lupin's Goa plant: USFDA finds certain investigation, material testing deficiencies

Drugmaker Lupin's Goa oral solid formulation facility has received seven observations from US Food and Drug Administration (USFDA), which is mostly related to investigation of out-of-specification (OOS) drug productions and testing deficiencies of input materials, among others.

There are no observations related to data integrity.

The inspection was carried out from September 6, 2021 to September 18, 2021 and closed with seven

observations.

Moneycontrol saw a copy of the Form 483, where the USFDA inspectors issue their observations at the end of an audit.

The seven observations included firm did not extend unexplained discrepancy investigation to other products; material not tested by quality control in process; drug product and in-process material did not confirm the specification; component's supplier report is deficient, test results not validated; quality standards record evaluation is deficient; access to labeling area not limited to authorised personnel and written stability program not followed.

Lupin said it was confident of addressing the observations satisfactorily

"..are committed to be compliant with Good Manufacturing Practice standards across all our facilities," the company said.

Lupin has been under USFDA scanner for some time over compliance issues. Along with Goa (oral solids), Indore Unit-2 (makes oral solid and ophthalmic formulations), Mandideep Unit-1 (cephalosporins) and Somerset plants are under warning letters.

The Goa facility has been a USFDA scanner since 2017. The facility was a significant contributor to exports.