FDA Cites Colorado Device Firm Over Procedural Issues

Multisource Manufacturing drew a Form 483 for failing to adequately establish or validate various procedures at its Colorado medical device facility, the FDA found in a November site inspection.

The FDA investigator observed that the facility had not validated its automated milling and lathing processes.

In addition, the instruments, which the firm used to manufacture its blunt tips and linear probes, did not have all of their parts verified.