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Medical Devices / Inspections and Audits

Validation Issues Uncovered at Dannoritzer

Nov. 21, 2018
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Germany’s Dannoritzer Medizintechnik received a six-item Form 483 from the FDA following a Feb. 5 to Feb. 8 inspection of its Baden-Wuttemberg facility for inadequate validation and process control procedures for its surgical equipment.

The FDA said the firm couldn’t provide evidence that some of its processes were validated. For example, the instructions for use for one device specified that cleaning be performed by machine or manual methods, but manual cleaning was not challenged during the validation.

Procedures for monitoring and controlling process parameters for a validated process were also found to be inadequate.

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