Vikshara says plant banned by US FDA has stopped making APIs

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The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.

The US regulator made the accusation in a warning letter published on Tuesday.

The agency said it has evidence Vikshara manufactured active pharmaceutical ingredients (APIs) at the site in July despite claiming that industrial action, which disrupted production and delayed an inspection in June, was ongoing.

It said: “On July 15, 2016, you informed FDA that your employees remained on strike. On August 8, 2016, you provided purported evidence of the strike, including copies of employee resignation letters and a photograph of striking employees blocking the entrance to your facility.

Despite your assertions that your employees were on strike, FDA obtained evidence that your firm actively manufactured numerous products…between July 11, 2016 and August 9, 2016.”

The Food and Drug Administration (FDA) added that: “Your false statements to FDA regarding the purported strike at your facility delayed FDA’s scheduling and conducting of a pre-announced inspection.”

Inspection

The US FDA also said that when it gained access to the facility on October 18, Vikshara had hindered the inspection. It accused the firm of locking doors prevent agency staff from accessing packaging and labelling areas.

The FDA also said Vikshara had failed to provide it with batch records, adding that it had not submitted the records electronically after the inspection was completed despite agreeing to do so.

The US regulator said it had placed Vikshara on Import Alert 66-40 on February 8, 2017, and on Import Alert 99-32 on February 9, 2017. According to the import alert the facility produces antibiotics and ingredients for cosmetics.

Response

Vikshara director Ankur Patel would not comment on the allegation the firm had made false statements to the FDA when contacted by in-Pharmatechnologist.com, but did tell us the firm had responded to the agency.

He also told us “We closed the facility already” but declined to provide further information.

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