Intas on import alert as FDA flags data manipulation, management failures in warning letter

Drug manufacturer Intas Pharmaceuticals is no stranger to FDA scrutiny. Now, one of its plants has been placed on an import alert after a series of interactions with the agency.

After a May inspection of Intas' plant in Gujarat, India, the FDA published a warning letter that points a finger at management and labels products made at the site "adulterated" because of the company's manufacturing deficiencies.

Before this development, the FDA earlier this year slapped the site with a Form 483 filing outlining problems at the plant. Shortly after that, the company provided a response that proved to be "inadequate," as the FDA described it.

In the warning letter, the FDA blasted Intas for an “egregious pattern” of shortfalls that shows the company's failure to carry out "basic responsibilities."

The agency tracked multiple instances of data manipulation going back to 2021. In these cases, visual inspectors manipulated particle and other defect counts to keep finished batches within rejection limits, according to the FDA.

In addition, Intas has yet to address the overall failures by the company's management, the FDA said.

“You lack a comprehensive review of the management of your operations, including but not limited to ineffective supervision and governance in your production department,” the warning letter read.

As of earlier this month, the manufacturer is on an FDA import alert.

Intas has been on the receiving end of some harsh FDA citations just this year. In August, one warning letter revealed that an analyst destroyed documents “by pouring acetic acid in a trash bin containing analytical balance strips,” the agency said in its report.