# FDA 483 - The American National Red Cross - September 23, 2010

Source: https://www.globalkeysolutions.net/records/483/the-american-national-red-cross/21180c03-9522-464d-ae13-52c7e336004b

> FDA 483 for The American National Red Cross on September 23, 2010. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The American National Red Cross
- Inspection Date: 2010-09-23
- Office Name: Cincinnati District Office
- Summary: The FDA Form 483 details multiple violations observed during an inspection. The facility failed to concurrently maintain records for blood and blood component storage, specifically discarding an invalid Weekly Inventory Reconciliation from April 6, 2009, and re-performing it on April 7, 2009.

Several instances of not following written standard operating procedures (SOPs) for blood and blood component collection, processing, and storage were cited. This included failure to follow Job Aid 15.4Jd037, "Short Loss of Consciousness," for donors experiencing loss of consciousness and bladder control, leading to incorrect classification of reactions (e.g., treating a long loss of consciousness as "Major Other" or "Prolonged Recovery" instead of "Long Loss of Consciousness").

Additionally, the facility failed to follow Work Instruction 15.3.56, "Final Donor Compilation Quality Review," as multiple Donor Reaction and Injury Records lacked the required final quality review. There was also a failure to adhere to Form Instruction 15.4Jm015 and Work Instruction 15.3.045 regarding timely supervisor/designee and medical director reviews for donor complications, with significant delays observed in follow-up and review processes.

Furthermore, the facility did not follow Job Aid 10.4Jd032, "Guidelines for Self-Detected Problems," as a donor's reaction was not documented as

## Related Officers

- [Nancy L. Neiger](https://www.globalkeysolutions.net/people/nancy-l-neiger/c3209528-eeb3-4a5f-88b1-f503798ed4c5)

Company: https://www.globalkeysolutions.net/companies/the-american-national-red-cross/0af3ae07-4a31-4da9-a531-691b481035b7

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22