# FDA 483 - Hampton Medical Devices, LLC - November 08, 2021

Source: https://www.keypedia.com/records/483/hampton-medical-devices-llc/eae09cb3-69a8-40a9-a84d-86ec8dfbd6ff

> FDA 483 for Hampton Medical Devices, LLC on November 08, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hampton Medical Devices, LLC
- Inspection Date: 2021-11-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Hampton Medical Devices, LLC in Festus, MO, was inspected by the FDA, revealing significant deficiencies in its quality system for medical device manufacturing. The inspection identified repeated violations across multiple areas, including process validation, contamination control, corrective and preventive actions, record keeping, equipment calibration, and quality audits. These issues indicate a systemic failure to maintain adequate control over manufacturing processes and product quality.

## Related Officers

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

Company: https://www.keypedia.com/companies/hampton-medical-devices-llc/90e4c057-8411-4ec4-b0d3-100857fb5105

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8