The QMN Weekly Bulletin

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

July 28, 2017

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

The agency issued a Form 483 following a May inspection of the firm’s Indianapolis facility. Inspectors found the company had no requirements for analyzing whether complaints warrant investigations. Lantz also lacked procedures for evaluating complaints to determine whether they must be reported to the FDA as an MDR, and it had no procedures for MDR submissions.

Investigators also highlighted Lantz’s CAPA procedures, noting they did not require analysis of quality data for the company’s Vector I Hand Rehabilitation System. The company also had insufficient procedures for ensuring conformance and design control, receiving or inspecting components, or maintaining device history records.

Lantz lacked procedures for selecting suppliers or for performing quality audits. The company also failed to document management reviews from June of 2014 to May 2017. The facility’s document control procedures did not require changes to be approved before implementation.

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