# FDA 483 - Lantz Medical, Inc. - August 23, 2019

Source: https://www.keypedia.com/records/483/lantz-medical-inc/d41e5827-127b-4d35-b2c4-1a8b50952643

> FDA 483 for Lantz Medical, Inc. on August 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lantz Medical, Inc.
- Inspection Date: 2019-08-23
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.keypedia.com/companies/lantz-medical-inc/a750fe75-aedf-4d1d-b314-17b76be54ae9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0