FDA Import Alert for inadequate Inspection Management

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

An Indian drug manufacturing facility received a Warning Letter and an import alert because FDA investigators were detained from doing their job properly.

It started with a strike. According the Warning Letter, the company informed FDA that "workers and staff have gone on strike" and "blocked off the entrance of the facility" one week before the scheduled inspection. As a result, the FDA cancelled this pre-announced inspection. And the company kept on communicating that the strike is ongoing. However, "FDA obtained evidence" that the company was manufacturing during this time period.

When FDA finally inspected the facility a few months later, the company didn't really support the inspection process adequately:

• Doors were locked
• Batch records were not provided
• Lights were off (and the investigator "had to perform parts of the walkthrough in the dark, using a flashlight")

As a result, FDA placed the company on Import Alert 66-40 and on Import Alert 99-32.

Find out more details in the FDA Warning Letter an Vikshara Trading & Investments Ltd.