AMO Uppsala AB – FDA 483

An FDA inspection of AMO Uppsala AB in Uppsala, Sweden, a medical device manufacturer, identified significant issues in process validation and nonconformance management. The firm's validation protocols for device manufacturing were found to be inadequate, lacking comprehensive testing, proper documentation, and calibration procedures. Additionally, the inspection revealed deficiencies in documenting and evaluating nonconforming devices, including instances of devices being reprocessed without proper tracking and devices falling on the floor without being identified as nonconforming.