# FDA 483 - Keller Laboratories - April 06, 2026

Source: https://www.keypedia.com/records/483/keller-laboratories/2486fa14-6fc5-4b69-9e09-92644d8a49d7

> FDA 483 for Keller Laboratories on April 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keller Laboratories
- Inspection Date: 2026-04-06
- Product Type: device
- Office Name: Kansas City District Office
- Summary: National Dentex LLC, dba NDX Keller, a medical device manufacturer in Fenton, MO, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in their quality management system, including a lack of a risk-based approach, failure to include Unique Device Identifiers on device labeling, and inadequate maintenance of design and development files for medical devices. These issues indicate a moderate level of non-compliance with medical device regulations.

## Related Documents

- [483 - 2023-03-17](https://www.keypedia.com/records/483/keller-laboratories/d8ac52eb-74d2-467c-b61e-49e128d93e6b)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/keller-laboratories/7cff8918-be58-467a-904d-3a4095742bc9

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79