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FDA Issued Warning Letter to Vikshara Trading and Investments Ltd

FDA issued a Warning Letter and an import alert to Vikshara Trading & Investments Ltd, an Ahmadabad based manufacturing facility. During the inspection, FDA investigators were stopped from inspecting the facility.

According to the Warning Letter, inspectors documented that the firm delayed and limited an FDA inspection. The company cited that "workers and staff have gone on strike" and "blocked off the entrance of the facility" before the scheduled inspection. Therefore, FDA had to cancel its pre-announced inspection. False statements to FDA regarding the purported strike at manufacturing facility were given even in the following week. However, through its confirmed sources, FDA was informed that the manufacturing facility was fully functional despite the strike and lockout period.

Following inspection of the facility a few months later, the company didn't really support the inspection process adequately:

Consequently, FDA placed the company on Import Alert 66-40 and on Import Alert 99-32.


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