FDA Warns Indian Firm for Impeding Inspection

Posted 09 May 2017 By Michael Mezher

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The US Food and Drug Administration (FDA) in April warned Indian pharmaceutical manufacturing company Vikshara Trading & Investments Ltd for attempting to avoid an inspection by pretending its employees were on strike and for poor conditions inside its facility.

According to FDA, the agency cancelled a pre-announced inspection of Vikshara's facility last June after the company said its workers had gone on strike and blocked the entrance to the facility less than 10 days before the inspection was scheduled to take place.

Vikshara continued to purport that its employees were on strike in July and August, and FDA says the company even provided copies of employee resignation letters and a photograph showing employees blocking the entrance to the facility as evidence of the strike.

However, FDA says it obtained evidence that that the company was still manufacturing products, including multiple batches of drugs, at the same time it said its employees were on strike.

Then, when FDA investigators actually visited Vikshara's facility in October, the agency says the company further impeded the inspection by blocking access to certain parts of the facility and not turning over requested batch records.

"Your firm's actions during this inspection significantly hindered FDA from fully assessing your compliance with [current good manufacturing practice] cGMP. For example, doors to the [redacted] vessel room and packaging and labeling storage areas were locked, impeding reasonable access for the investigator to these areas," FDA writes.

According to FDA, Vikshara said it would provide the batch records electronically within a few days of the inspection but has yet to do so.

FDA also says the facility was "unkept" and that its investigator was forced to use a flashlight to see properly during parts of the inspection.

"Even with limited visibility, our investigator observed [redacted] powder scattered throughout the production areas, including powder caked on the floor. In addition, our investigator observed empty boxes, trash, finished drug products covered in powder, and containers littered throughout the facility," FDA writes.

As a result, FDA placed the company on import alert in February for refusing inspection and for failing to comply with GMP.

FDA

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Categories: Drugs, Compliance, Manufacturing, News, US, India, FDA

Tags: Inspection, Warning Letter

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