# FDA 483 - Fedex Supply Chain, Inc. - July 23, 2021

Source: https://www.keypedia.com/records/483/fedex-supply-chain-inc/82e9b424-ff23-4eb2-a4f0-449f24f103e8

> FDA 483 for Fedex Supply Chain, Inc. on July 23, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fedex Supply Chain, Inc.
- Inspection Date: 2021-07-23
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Fedex Supply Chain, Inc. in Memphis, TN, a repackager/relabeler of medical devices, was cited for two observations during an FDA inspection. The firm failed to adequately validate a freezer used for temperature-sensitive Class II medical devices, specifically regarding capacity testing. Additionally, process validation results for freezer units were not adequately documented, with initial system settings being photocopied without contemporaneous records.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)
- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)

Company: https://www.keypedia.com/companies/fedex-supply-chain-inc/0fa35288-7471-4a59-a1a3-7d19a82d5a16

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