Teligent Slammed By FDA Warning Letter
Criticized For Lax Approach To Complaint Handling And Stability Testing
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
You may also be interested in...
After filing for Chapter 11 bankruptcy protection in October last year, Teligent has sewn up the sales of its Buena manufacturing site and ANDAs, with an auction process providing mixed results.
Opening bids totaling $64m have been submitted for bankrupt Teligent’s assets across the US and Canada, weeks after the injectables specialist entered Chapter 11 bankruptcy proceedings.
Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.