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The FDA rapped Newton, North Carolina devicemaker Sarstedt after a June 28 to July 2, 2018 inspection revealed deficiencies in its document change and labeling procedures. Read More
The FDA hit Imaging Biometrics with a Form 483, calling the Elm Grove, Wisconsin healthcare software developer out for its medical device reporting procedure and complaint records. Read More
The FDA cited Acorda Therapeutics’ Chelsea, Massachusetts manufacturing facility for its handling of discrepancy investigations observed during a June 4-18, 2018 inspection. Read More
The FDA flagged the facility for environmental monitoring and a facility investigation, as well as a deviation and calibration out of tolerance discrepancy. Read More