# FDA 483 - Edge Biologicals Inc - April 04, 2023

Source: https://www.globalkeysolutions.net/records/483/edge-biologicals-inc/a1a13ec9-af8a-4dc3-9709-6cac6bbb045b

> FDA 483 for Edge Biologicals Inc on April 04, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edge Biologicals Inc
- Inspection Date: 2023-04-04
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Edge Biologicals Inc in Memphis, TN, was inspected and received a Form FDA-483 with eight observations, many of which were repeat findings from previous inspections. The inspection revealed significant deficiencies in quality system procedures, including validation of aseptic processes, corrective and preventive actions, supplier quality, environmental monitoring, and employee training. These issues indicate a systemic lack of control over manufacturing processes for culture media devices and suggest a high risk of product compromise and non-compliance with regulatory requirements.

## Related Documents

- [483 - 2024-11-22](https://www.globalkeysolutions.net/records/483/edge-biologicals-inc/5f161c54-e882-4a73-b137-36fba38c5926)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/edge-biologicals-inc/ffa7d4eb-c5ec-4748-bca7-f26a2e7ca01e

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