# FDA WARNING_LETTER - Sibley Memorial Hospital - September 18, 2009

Source: https://www.keypedia.com/records/warning_letter/sibley-memorial-hospital/47a80585-3dca-4276-bc0c-4412da4a5a82

> FDA WARNING_LETTER for Sibley Memorial Hospital on September 18, 2009. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sibley Memorial Hospital
- Inspection Date: 2009-09-18
- Product Type: Biologics
- Office Name: Baltimore District Office
- Summary: On December 15, 2009, the FDA issued a Warning Letter to Sibley Memorial Hospital following an inspection from September 14-18, 2009. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for blood and blood products (21 CFR Parts 600-680), rendering their products adulterated under Section 501(a)(2)(B) of the FD&C Act.

Key violations include:
1.  **Failure to notify transfusion recipients of positive supplemental test results (21 CFR 610.47(b)(3)):** A recipient of a unit transfused in 1998 was not notified of the donor's subsequent positive HCV supplemental test result, discovered only during the FDA inspection.
2.  **Failure to maintain complete and traceable records (21 CFR 606.160):** Records for blood components sent for irradiation lacked details such as shipment/return dates/times, RadSure label inspection, and conversion to irradiated status.
3.  **Failure to review records and investigate discrepancies (21 CFR 606.100(c)):** Irradiation logs and electronic records were incomplete/inconsistent and not reviewed before product release. Additionally, five instances of failure to perform antigen typing lacked documented investigations, conclusions, or follow-up.
4.  **Failure to

## Related Officers

- [District Director](https://www.keypedia.com/people/evelyn-bonnin/3fdb9ef8-ea23-4a86-9176-cab37e5dea36)

Company: https://www.keypedia.com/companies/sibley-memorial-hospital/77edabf3-8484-4b7f-8809-a3373fb12ec5

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