Drugs

India’s Skylark CMC Refuses FDA Inspection

David McFarland

— 1 min read
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FDA says Skylark CMC Pvt. Ltd., Gujarat, India, refused to cooperate with a FDA inspection beginning 6/25. A 12/3 Warning Letter says the company: 

  •          barred access to manufacturing areas; and
  •          refused to provide copies of records sought by the inspector.

The letter says FDA conducted an unannounced inspection of the facility because research indicated it has the same physical address as Vikshara Trading & Investments Ltd., which is currently subject to an FDA import alert. Skylark was placed on import alert 11/8.

Until FDA is permitted to inspect the facility and confirm compliance with current good manufacturing practice regulations, the letter says, the agency may withhold approval of any new applications or supplements listing Skylark as a drug manufacturer. And shipments of articles manufactured at the Skylark facility are subject to refusal of admission into the U.S., the letter says.

Skylark was told to respond to the Warning Letter within 15 days.

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