FDA hits Lupin with another warning notice for troubled API plant

Lupin is having continued difficulty solving problems at its factory in Tarapur, India, and has received another warning letter from the FDA, the generics producer revealed in a regulatory filing.

This comes on top of the FDA slapping Lupin with a Form 483 letter in April after the regulator inspected the active pharmaceutical ingredient (API) plant from March 22 to April 4.

In its notice to the National Stock Exchange of India and the Bombay Stock Exchange, Lupin did not specify the most recent issues cited by the FDA.

“The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,” Lupin wrote.

In April, the FDA chided Lupin for inadequate cleaning protocols and failure to establish in-process samples and controls. Lupin’s investigations into plant deficiencies were lacking, the regulator added.

The FDA’s problems with the facility date to January of 2020 when the regulator stamped it with Official Action Indicated status, meaning “objectionable conditions were found and regulatory action should be recommended,” as explained online.

Lupin has often been a target for FDA scrutiny. In 2019, its plant in Mandideep, India, was hit with a warning letter that flagged a variety of manufacturing and data safety issues. Five months later, Lupin’s facility in Andhra Pradesh was cited with five observations in a Form 483 letter.

But Lupin’s issues with the FDA aren’t limited to plants in India. In 2020, its U.S. subsidiary, Novel Laboratories, was dinged for a variety of cleaning, consistency and quality control problems at its site in Somerset, New Jersey.

At the time, given Lupin’s long list of infractions, the FDA added a sweeping rebuke of how the company did business.

“Corporate oversight and control over the manufacture of drugs is inadequate,” the FDA wrote.