Three Foreign Drugmakers on Import Alert, FDA Says in Letters

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

Apotex Research Private Ltd.

• Issuing Office: FDA Center for Drug Evaluation and Research
• Recipient: Ravinder Kumar (managing director)
• Date: Aug. 9 (posted Aug. 14)
• Inspection of facility in Bangalore, India, from Nov. 6 to 17, 2017.

Alleged Infractions

• Failure to investigate any unexplained discrepancies in finished products regardless of whether it had been distributed.
• Failure to establish a system to ensure quality of products.
• Failure to fix problems the FDA brought up in previous warning letters regarding global quality oversight.

Actions or Penalties ...