FDAnews Device Daily Bulletin

Lantz Medical Lands Form 483 Over Lack of Procedures, Device History Records

Aug. 7, 2017

The FDA put Lantz Medical on notice for issues ranging from undefined complaint procedures to lack of procedures or device history records.

The agency issued a Form 483 following a May inspection of the devicemaker’s Indianapolis facility. They found the company had no requirements on analyzing to determine whether complaints warrant investigations. Lantz further had no requirements for evaluating complaints to determine whether they must be reported to the FDA as an MDR. Investigators further found the firm had no procedures for MDR submission at all.

Investigators also highlighted Lantz’s CAPA procedures, noting that they did not require analysis of quality data for the company’s Vector I Hand Rehabilitation System, nor did they identify what sources of quality data were available.

View today's stories