FDA Observes Faulty Procedures at OMT Facility

OMT landed a Form 483 citing its handling of complaints, design controls, and other issues.

After visiting the company’s Hollywood, Fla., facility in November 2016, the FDA inspector observed that a complaint regarding a device that malfunctioned during surgery was not evaluated according to OMT’s procedures and was not reported to the FDA.

The inspector also found the facility did not properly implement design control procedures. One product’s design history file did not include approved inputs, there was no evidence that design changes were validated, and the results of a design risk analysis were not adequately documented.