# FDA 483 - American Red Cross - September 07, 2023

Source: https://www.globalkeysolutions.net/records/483/american-red-cross/cb90511d-5556-4eec-8af2-f7b4cc1b77a8

> FDA 483 for American Red Cross on September 07, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Red Cross
- Inspection Date: 2023-09-07
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: The FDA issued a Form 483 to American Red Cross in Virginia Beach, VA, following an inspection from September 5-7, 2023. The inspection revealed a significant issue related to the improper storage of platelet units, specifically regarding temperature control and agitation immediately after collection and resuspension. This indicates a critical lapse in maintaining product quality and safety standards.

## Related Officers

- [Kenneth L. Smalls](https://www.globalkeysolutions.net/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)

Company: https://www.globalkeysolutions.net/companies/american-red-cross/42d2abfe-1150-46da-a6f0-cce7bf30f838

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64