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Teligent Slammed By FDA Warning Letter

Criticized For Lax Approach To Complaint Handling And Stability Testing

 
• By Joanne S. Eglovitch

Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.

Warning Rubber Stamp
FDA Says Teligent Needs To Up Its Complaint Handling Game • Source: Shutterstock

The US Food and Drug Administration has rebuked New Jersey drug manufacturer Teligent for lax handling of product complaints associated with generic topical products and for pulling stability samples without immediately testing them. The firm was also cited in a recent warning letter for not filing field alert reports in a timely manner.

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