# FDA 483 - American Natl. Red Cross-Greater Chesapeake & Potomac Region - June 23, 2008

Source: https://www.keypedia.com/records/483/american-natl-red-cross-greater-chesapeake-potomac-region/c782f222-7202-4976-b36b-dfaa27b99a1c

> FDA 483 for American Natl. Red Cross-Greater Chesapeake & Potomac Region on June 23, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Natl. Red Cross-Greater Chesapeake & Potomac Region
- Inspection Date: 2008-06-23
- Product Type: Devices
- Office Name: Baltimore District Office
- Summary: The FDA Form 483 details multiple significant deficiencies at the Greater Chesapeake and Potomac Region facility.

**Facility and Operation Details:** The facility is involved in the collection, processing, and distribution of whole blood and blood components, including leukoreduced red blood cells and platelet products.

**Violations and Observations:**

1.  **Overweight Whole Blood Units:** The region failed to identify, investigate, correct, and trend 197 instances of overweight whole blood units collected between November 2006 and May 2008. This violates step 3 of a redacted SOP requiring deviation logging, tracking, and trending. This issue was previously cited in April-June 2002 and September-January 2006 FDA inspections, indicating ineffective corrective actions.
2.  **Inadequate Manufacturing Record Reviews and Non-Conforming Products:**
    *   **Irradiated RBCs without Second Party Review:** On 12/31/07, 10 leukoreduced red blood cells were distributed on 11/22/07 without required second-party review of the irradiation batch record. The investigation (Exception Report redacted) lacked root cause analysis and a formal Corrective Action Plan (CAP). Consignees were notified eight days after discovery, exceeding the 48-hour requirement of Paragraph X.E of the April 15, 2003 Amended Consent Decree.
    *

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## Related Officers

- [Investigator](https://www.keypedia.com/people/linda-s-mattingly/4abdc255-a72e-475f-b3e3-1b68bf94d3b8)

Company: https://www.keypedia.com/companies/american-natl-red-cross-greater-chesapeake-potomac-region/aedf322a-3642-48f6-a582-7d897fc96eec

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