# FDA 483 - Albahealth LLC - March 17, 2022

Source: https://www.globalkeysolutions.net/records/483/albahealth-llc/127fde6d-e972-47b8-88cc-b2960de96644

> FDA 483 for Albahealth LLC on March 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Albahealth LLC
- Inspection Date: 2022-03-17
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Albahealth LLC in Rockwood, TN, conducted from March 15-17, 2022, identified a significant documentation deficiency. The firm failed to fully document rework and reevaluation activities in the device history record. This included a lack of documented review and disposition for nonconforming products, such as unsealed compression stocking bags.

## Related Officers

- [Benjamin E. Bowen](https://www.globalkeysolutions.net/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.globalkeysolutions.net/companies/albahealth-llc/dcff86f8-a270-4f24-88f1-e18fb376213c

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