# FDA 483 - MANAMED INC. - May 21, 2024

Source: https://www.globalkeysolutions.net/records/483/manamed-inc/c71dec8b-6d90-415a-96c7-230d78824695

> FDA 483 for MANAMED INC. on May 21, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MANAMED INC.
- Inspection Date: 2024-05-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: MANAMED INC., a specification developer for Class II sequential compression devices in Denton, TX, was cited for significant deficiencies across its quality system. The inspection revealed failures in establishing and maintaining critical procedures for medical device reporting, corrective and preventive actions, supplier controls, design controls, and acceptance activities. Additionally, device master records and device history records were found to be inadequately maintained, indicating a systemic lack of control over product quality and regulatory compliance.

## Related Officers

- [Jacey Roy](https://www.globalkeysolutions.net/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.globalkeysolutions.net/companies/manamed-inc/5e64cefc-7fed-4dc0-9fa9-0d0f005e6557

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