Orchid Orthopedics Gets Form 483 for Software Validation

Orchid Orthopedics Solutions received a Form 483 after inspectors found that the company failed to validate computer software and properly document rework and re-evaluation activities.

After an inspection of the medical device development and manufacturing company’s Memphis, Tenn., Facility in March, it was discovered that Orchid failed to validate computer software used as part of production.

The FDA also found that device history records showing rework and reevaluation activities did not include a determination of whether there had been any adverse effects from these activities on the devices. In addition, rework procedures did not require an adverse effect determination to be made.

Read the Form 483 here: www.fdanews.com/12-09-16-Orchid.pdf.