483
Lantz Medical, Inc.Lantz Medical, Inc. – FDA 483, Aug 23, 2019
Record Details
Kant> Medical, Inc. in Indianapolis, IN, was inspected and received a Form FDA 483 with seven observations related to significant deficiencies in their quality system. The inspection revealed inadequate procedures for complaint handling, CAPA, nonconforming product control, quality audits, and device history records. Additionally, the firm failed to document software validation and establish a design history file for their Vector 1 Hand Rehabilitation System.
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ID · d41e5827-127b-4d35-b2c4-1a8b50952643
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