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FDAnews Drug Daily Bulletin

FDA Warns API Manufacturer in India

May 16, 2017

The FDA issued warnings to Indian API manufacturer Vikshara Trading and Investments over serious violations, including hindering the agency’s investigation.

A scheduled visit by FDA inspectors last summer to the Vikshara facility in Ahmedabad, India, was delayed by labor problems until October after the company claimed its workers were on strike from June 2016 until sometime in August 2016.

However, the agency found evidence that the company manufactured drugs between July 11, 2016 and Aug. 9, 2016, according to the warning letter.

When the inspection finally occurred, the company “significantly hindered” the process with inspectors encountering locked doors. In addition, they observed lights permanently out, powders caked on the floor and scattered through production areas and empty boxes and trash tossed around the facility.

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