Germany’s Dannoritzer Medizintechnik received a six-item Form 483 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. The 483 said that usability of the Instructions for Use by the intended population also was not validated.
Procedures for monitoring and controlling process parameters for a validated process were also found to be inadequate and parameter settings used during production were not routinely documented in the device history record.
The FDA also cited the firm for failing to establish schedules for adjustment, cleaning and maintenance of equipment. For example, there was no documentation for equipment calibration.
Read the Dannoritzer Medizintechnik Form 483 here: www.fdanews.com/11-15-18-dannoritzermedizintechnik483.pdf.