# FDA 483 - MIDWAY MEDICAL - January 15, 2026

Source: https://www.keypedia.com/records/483/midway-medical/72a91845-33c5-4afc-b84b-6765851e8562

> 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: FDA District Office — Chicago, Illinois
- 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 their quality system, primarily concerning the lack of established written procedures for complaint handling, purchase controls, MDR reporting, and corrective and preventive actions. Additionally, the firm failed to submit required information to the Global Unique Device Identification Database for their Class II medical device.

## Related Documents

- [483 - 2026-01-15](https://www.keypedia.com/records/483/midway-medical/05a35e27-60b7-4f1f-a5af-e34be26fd4ce)

## 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/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65