Regulatory Focus™ > News Articles > FDA Warns Indian Contract Manufacturer Hetero Labs

FDA Warns Indian Contract Manufacturer Hetero Labs

Posted 29 August 2017 | By Zachary Brennan 

FDA Warns Indian Contract Manufacturer Hetero Labs

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to India-based contract manufacturer Hetero Labs’ manufacturing site on the outskirts of Hyderabad for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

The inspection from December 2016 found the firm failed to properly investigate process deviations and out-of-specification (OOS) laboratory results, manufacturing equipment in poor condition and failures of the site’s quality control unit to follow written procedures regarding the recall of failing products.

For instance, the warning letter notes that on 8 July 2016, Hetero received a complaint that one tablet in a bottle of 5 mg finasteride tablets was approximately double the thickness of the others.

“You confirmed the defect after receiving the complaint sample on July 27, 2016, but did not initiate a product recall as directed by your own procedures until December 23, 2016. This was nearly a week after our investigators pointed out your failure to take action as directed by your own procedures regarding recalls of defective products,” FDA says.

The agency also said the company “does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality” and it recommends that the firm engage with a consultant.

Warning Letter


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.