India's Hetero Labs lambasted in FDA warning letter

Hetero Labs Jadcherla plant
The FDA has issued a warning letter for this Hetero Labs finished formulations plant which it said failed CGMP standards.

The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found. A warning letter cited concerns about cleanliness, quality controls and handling of customer complaints.

In fact, in an Aug. 15 warning letter that was posted Tuesday, the FDA said the Indian drugmaker should consider hiring a consultant that it can help it get its manufacturing act together at the facility in Jadcherla Mandal.

Hetero Labs has gained attention by launching in India biosimilars of some of the world’s top cancer drugs. But the warning followed a December 2016 inspection of a formulations plant in which inspectors noted, among other problems, colored residue clinging to some manufacturing equipment. The agency was not satisfied with the company’s response that it had tested the substance and it met microbiological acceptable levels for contaminants.

There were also concerns over what the FDA saw as an inadequate investigation into customer complaints about an unnamed drug that failed dissolution testing. In fact, the agency told Hetero it wants a detailed retrospective review of the manufacturing process validation for each product that it is approved to export to the U.S. to ensure it can consistently produce drugs that meet quality standards.

The FDA faulted the facility’s quality control operations, saying the unit didn’t follow its own written procedures that would have required a product recall after a customer complained that a 5 mg finasteride tablet was found to be double the thickness of the others.

The warning letter made no mention of data integrity, even though a 13-page Form 483 from the inspection had noted (PDF) that video footage showed Quality Assurance employees shredding documents in the middle of the night and hiding some of them in their pockets. Inspectors found post-dated documents among those that had been discarded.