# FDA 483 - The American National Red Cross - April 25, 2008

Source: https://www.keypedia.com/records/483/the-american-national-red-cross/12dcb665-2c6f-4873-83a6-ca3c73d05ccd

> FDA 483 for The American National Red Cross on April 25, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The American National Red Cross
- Inspection Date: 2008-04-25
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: The FDA inspection of this firm revealed multiple deficiencies in its quality system and adherence to regulatory requirements for blood and blood components.

**Observation 1** details failures in promptly and adequately investigating, correcting, and preventing recurrence of problems. Examples include:
*   A February 23, 2007, problem regarding incomplete/incorrect donor records (Apheresis Donor Continuous Record) had a failed effectiveness check, but no follow-up or re-evaluation of the corrective action occurred as of April 17, 2008.
*   An investigation initiated on January 24, 2008, for a trend of incomplete/incorrect/unreviewed Apheresis Alarm Logs was not completed by April 17, 2008.
*   An employee's third instance of documenting an illogical donor temperature on December 31, 2007, resulted in verbal counseling, despite the corrective action requiring written counseling for a third offense.

**Observation 2** highlights the firm's failure to notify consignees and/or FDA's Baltimore District Office within 48 hours of distributing unsuitable blood or blood components. Specific instances include:
*   Twenty-six RBC units, incorrectly stored and then distributed on March 20, 2007, lacked the required 48-hour notification to FDA.
*   Fresh frozen plasma components failing manufacturing timeframe requirements, discovered December 8,

Company: https://www.keypedia.com/companies/the-american-national-red-cross/2999d89e-2e2d-4075-a4db-374f032ea973

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa