# FDA 483 - MIDWAY MEDICAL - January 15, 2026

Source: https://www.keypedia.com/records/483/midway-medical/05a35e27-60b7-4f1f-a5af-e34be26fd4ce

> FDA 483 for MIDWAY MEDICAL on January 15, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MIDWAY MEDICAL
- Inspection Date: 2026-01-15
- Product Type: device
- Office Name: Chicago District Office
- Summary: MIDWAY MEDICAL, a specification developer in Bloomington, IL, was inspected and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, primarily due to the lack of established written procedures for critical processes such as complaint handling, purchase controls, medical device reporting (MDR), and corrective and preventive actions (CAPA). Additionally, the firm failed to submit required information to the Global Unique Device Identification Database for its Class II medical device.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/midway-medical/d03a5807-9714-4bd8-9826-b4c84d6f3980

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669
