# FDA 483 - Reach Medical Inc. - December 30, 2022

Source: https://www.keypedia.com/records/483/reach-medical-inc/8f7a6262-2d92-4c9e-b8ca-a45264992a44

> FDA 483 for Reach Medical Inc. on December 30, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reach Medical Inc.
- Inspection Date: 2022-12-30
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Reach Medical Inc. in Collierville, TN, a medical device manufacturer, was inspected by the FDA from December 27-30, 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for CAPA, quality audits, complaint handling, device history records, product identification, and equipment calibration. These findings indicate a systemic failure to establish and follow required quality control procedures.

## Related Officers

- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)

Company: https://www.keypedia.com/companies/reach-medical-inc/32a23908-c251-4e56-b2b4-ea27a1ddc1e3

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea