FDA nails USV sterile injectables plant in India with warning letter, a second for the company

The FDA has issued a warning letter to a USV Private sterile injectables manufacturing plant in India.

An Indian drugmaker whose Mumbai plant got nailed by an FDA warning letter several years ago is again under the gun for making some of the same mistakes at a sterile drug manufacturing plant in India.   

The FDA posted a warning letter on Tuesday for USV Private’s finished pharmaceutical plant in in Dabhel, Daman, that followed a June inspection.

Among the issues inspectors noted were problems with methods used in the microbiology testing lab and shortcomings with how the plant handled smoke studies for an ISO 5 area on the vial-filling and capping line. They pointed to computer access issues after the plant found 25 deleted test results in the audit trails of two pieces of equipment. The FDA also noted a lack of commitment on the part of the company to investigating out-of-spec results.

The FDA acknowledged the company had hired a consultant to help it audit the plant’s processes but said the fact that some of the same issues had been noted in the 2014 warning letter to the Mumbai plant showed the company’s oversight and control over its manufacturing is "inadequate." Data integrity concerns were the focus of that letter.

While the FDA has been penalizing plants for years now over data integrity problems that it says raise questions about the safety and effectiveness of their drugs, it continues to be a recurring problem with Indian drugmakers.

For example, the FDA issued a Form 483 this year to a Hetero Labs formulations manufacturing plant in Jadcherla after video footage showed workers shredding what appeared to be manufacturing and packaging documents at 1 a.m. four days before an FDA inspection.