FDA 483 - Forcemech International LLC - April 06, 2023

Forcemech International LLC, a medical device repackager/relabeler in Pearland, TX, was cited for three observations during an FDA inspection. The firm failed to adequately examine labeling for accuracy, including Unique Device Identifiers (UDI), and did not establish sufficient procedures for servicing activities. Additionally, the device master record was not adequately maintained, specifically regarding labeling artwork for serial numbers on powered wheelchairs.