# FDA 483 - Rockwell Medical, Inc. - July 25, 2022

Source: https://www.globalkeysolutions.net/records/483/rockwell-medical-inc/05d8342e-08d5-424b-844b-1408fe2d0571

> FDA 483 for Rockwell Medical, Inc. on July 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockwell Medical, Inc.
- Inspection Date: 2022-07-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Rockwell Medical, a medical device manufacturer in Grapevine, TX, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, equipment calibration, and equipment maintenance. These issues indicate a systemic breakdown in ensuring product quality and compliance.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/olalere-d-fasipe/0dd0f0ae-07d9-40ab-b602-97521150d23d)
- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/rockwell-medical-inc/d6f8e621-31e0-49f4-993a-8b9bf8190150

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab