# FDA 483 - Sure-Tech Diagnostic Associates, Inc - July 29, 2026

Source: https://www.keypedia.com/records/483/sure-tech-diagnostic-associates-inc/038745be-d79e-446f-a929-ce10b81a5441

> FDA 483 for Sure-Tech Diagnostic Associates, Inc on July 29, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sure-Tech Diagnostic Associates, Inc
- Inspection Date: 2026-07-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Sure-Tech Diagnostic Associates, Inc. in Saint Louis, MO, was inspected by the FDA, revealing significant deficiencies in its quality management system documentation. The firm lacked documented procedures for risk management and supplier evaluation, and failed to establish a Medical Device File for its Fetal Hemoglobin Controls, indicating a broad failure to maintain required records and processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/sure-tech-diagnostic-associates-inc/cf867049-7c27-4dc8-8348-913176250103

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