Indian generic manufacturer Zydus Lifesciences was hit with an FDA warning letter on Tuesday after it shipped vitamin B injections containing glass particles.
An inspection from April 15 to April 23 at Zydus’ facility in Waghodia, a town in Gujarat, India, uncovered three major issues.
The FDA inspectors found the company distributed batches of cyanocobalamin injection, used to treat vitamin B deficiency, that could contain glass particles as small as 150 micrometers. Zydus didn’t locate the source of the glass and only used visual inspections to determine if injections were safe or not.
In response, Zydus said it had no customer complaints and that it stopped manufacturing the cyanocobalamin injections in August 2022, yet the FDA said this was “inadequate.” The company had to recall batches of the injections this past June.
Further, the FDA found issues related to cross-contamination that had been ongoing for three months. Surfaces and equipment weren’t properly cleaned, causing some product contact surfaces to be “stickier” than usual. The company then shipped drug batches that were related to other contaminated batches.
Inspectors also saw workers stretching over sterile vials and failing to properly conduct airflow studies to avoid contamination.
Finally, the FDA found problems in the company’s process performance qualifications for its manufacturing, stating there weren’t proper written instructions for employees to follow and certain data weren’t collected.
The agency has recommended that Zydus hire a third-party consultant and has given the drugmaker 15 days to respond. If the company fails to remedy the manufacturing problems, the FDA could prevent any of Zydus’ products from entering the US. Zydus did not immediately respond to a request for comment.