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Southeastern Michigan Region

Southeastern MichiganFood and Drug Administration Adverse Determination Letter (ADL)     VIEW | DOWNLOAD

FDA Inspection: Southeastern Michigan Region, (09/27/10)      SNIPPET | DOWNLOAD

 

 

 

 

 

 

 

Recalls and Significant Blood Safety Violations

10/30/09:
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The following excerpt is from page 3 of this 8-page FDA Inspection Report:

[REDACTED TEXT] On 03/10/09 first time donor [REDACTED TEXT] reported experiencing sharp shooting pain for which [REDACTED TEXT sought treatment at an emergency room.

[REDACTED TEXT On 03/17/09 donor [REDACTED TEXT experienced prolonged recovery and was admitted to the hospital.

[REDACTED TEXT -On 04/06/09 donor first time donor [REDACTED TEXT experienced numbness, coldness and pain and was treated in the emergency room.

[REDACTED TEXT - On 12/23/09 donor [REDACTED TEXT experienced a loss of consciousness/head injury and laceration over [REDACTED TEXT right eye and was transported to the emergency room

Download the pdf file to read the complete inspection report.

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