Regulatory Focus™ > News Articles > FDA Warns Valeant Over Quality System Violations

FDA Warns Valeant Over Quality System Violations

Posted 08 November 2016 | By Zachary Brennan 

FDA Warns Valeant Over Quality System Violations

In a letter dated 3 November and released Tuesday, the US Food and Drug Administration (FDA) warned Valeant Pharmaceuticals over quality system violations.

The warning letter comes as an inspection of the company’s Rochester, NY, site on 23 August 2016 through 1 September 2016 found Valeant’s “SPAG-2” and “ONSET Mixing Pen” devices are adulterated because design validation activities were not documented or performed.

In addition, FDA said corrective and preventive actions surrounding field action for the mixing pen were incomplete as they did not address or document how they affected existing product in inventory.

“The field action for ONSET Mixing Pens initiated on 1/26/16 requested users to stop the use of the device if it has been used for more than 18 months and included a determination to replace the pen after 18 months of use. Subsequent to the field action, multiple additional lots in inventory were shipped to customers without these field action notifications,” FDA said. 

The agency also found that Valeant’s non-conformance investigations are not always completely documented.

The warning letter comes as Valeant has dealt in recent months with a lengthy Senate investigation into the pricing of its drugs.

Warning Letter

 


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