Despite repeated manufacturing infractions this year, Lupin has found itself on the receiving end of yet another FDA rebuke.
Following an October FDA inspection, Lupin’s biotech manufacturing facility in Pune, India, has been slapped with a 17-observation Form 483. The company said in a release on the Bombay Stock Exchange that it’s committed to “expeditiously” addressing the regulator’s concerns.
Lupin doesn’t expect the FDA rebuke to put a squeeze on existing revenues from the facility, the company said.
Lupin did not detail the nature of the FDA’s citations. Fierce Pharma has submitted a Freedom of Information Act request to the FDA to obtain the Form 483, and we will update this story as we learn more.
Lupin has repeatedly run afoul of the FDA this year, receiving a warning letter last month and a separate Form 483 back in April.
The September warning letter was tied to Lupin’s factory in Tarapur, India, which had previously been tagged with Official Action Indicated status in January 2020, meaning “objectionable conditions were found and regulatory action should be recommended,” as the FDA explains online.
That warning letter followed an April Form 483 at the same Tarapur plant, which chided Lupin over inadequate manufacturing processes and subpar cleaning protocols, CNBC first reported earlier this year.
As for Lupin's latest infraction, 17 observations are a lot, though not entirely unheard of in the realm of FDA manufacturing oversight.
Back in September, Alvotech earned a 13-observation chiding related to procedural controls, management of manufacturing deviations, the presence of mold and bacteria in Alvotech’s plant and more.
Alvotech’s 483 came on the heels of the company’s announcement the FDA had slapped down its interchangeable Humira biosimilar prospect AVT02. The company said “certain deficiencies” uncovered during a March inspection of its Reykjavik, Iceland, manufacturing facility, triggered the FDA rejection.
Elsewhere, Sun Pharma in May received a 10-observation Form 483 in the wake of an FDA inspection at the company’s Halol manufacturing facility in Gujarat, India.
As with Lupin’s latest citation, Sun Pharma did not disclose details of the observations.