FDA Flags Blood-Drawing Device Manufacturer for CAPAs, Supplier Survey

The FDA hit Hummingbird Med Devices with a Form 483 over incomplete CAPA files and a missing supplier survey.

The Camano Island company, a specification developer for Class I blood-drawing devices, had two CAPA files that did not include all CAPA related activities, the agency found during an August inspection.

The firm had no completed survey for the supplier of a component used in its Hummi Micro-Draw device used for transferring blood from a UAC/UVC catheter to a blood collection device.