# FDA 483 - American National Red Cross, Penn Jersey Region - June 04, 2010

Source: https://www.keypedia.com/records/483/american-national-red-cross-penn-jersey-region/7e75bfaf-7466-4c8a-9db3-b28fd7afe181

> FDA 483 for American National Red Cross, Penn Jersey Region on June 04, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American National Red Cross, Penn Jersey Region
- Inspection Date: 2010-06-04
- Product Type: Drugs
- Office Name: Center for Biologics Evaluation and Research
- Summary: The FDA Form 483 details observations from an inspection, highlighting failures in quality systems and adherence to standard operating procedures.

**Key Violations and Observations:**

1.  **Inadequate Investigation and Follow-up of Discrepancies:**
    *   **Exception E-0585021 (5/21/09):** An employee performed an arm preparation inappropriately, affecting 359 whole blood units. While initial gain control was within 48 hours, three in-date AS-1 red blood cells (units 022N710611, 022N710613, 022N710616) were not recalled, and consignees were not notified until 5/28/10, after CBER inquiry on 4/5/10. A problem (E-031697) for recall follow-up failure was not logged until 6/2/10.

2.  **Failure to Follow Written Standard Operating Procedures (SOPs):**
    *   **Work Instruction 11.3.090 (Retrieval/Notification of Transfusable Components):**
        *   **Exception E-0501484 (1/9/09):** A male donor was registered as female, requiring retrieval. Initial notification was sent

## Related Documents

- [483 - 2008-07-29](https://www.keypedia.com/records/483/american-national-red-cross-penn-jersey-region/f4f02ace-10a4-4c5a-b864-043f4f156ba5)
- [483_RESPONSE - 2010-10-29](https://www.keypedia.com/records/483_response/american-national-red-cross-penn-jersey-region/3397e1ba-3dde-4d66-b19b-61e382b6d72a)

Company: https://www.keypedia.com/companies/american-national-red-cross-penn-jersey-region/7d2928f2-8d2a-48db-b0df-6c8a10016030

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d