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Recalls and Significant Blood Safety Violations

10/30/09:
Recalled 1 Platelets Pheresis Leukocytes Reduced Product due to component preparation (irradiation not performed in accordance with specifications).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

2/6/08:
Recalled 6 Red Blood Cells Products due to testing (failure to perform syphilis testing properly).

2/6/08:
Recalled 109 Red Blood Cells Leukocytes Reduced Products due to testing (failure to perform syphilis testing properly).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Irradiated Product due to testing (failure to perform syphilis testing properly).

2/6/08:
Recalled 6 Red Blood Cells Pheresis Leukocytes Reduced Products due to testing (failure to perform syphilis testing properly).

2/6/08:
Recalled 6 Platelets Products due to testing (failure to perform syphilis testing properly).

2/6/08:
Recalled 1 Fresh Frozen Plasma Product due to testing (failure to perform syphilis testing properly).

The following excerpt is from page 1 of this 2-page FDA Inspection Report:

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION #1: A failure to follow the Amended Consent Decree of Permanent Injunction #93-0949 dated April 15, 2003 Paragraph IV.B.I (c) and (d): requiring implementation and monitoring of detailed corrective action plans.

Specifically, Corrective Actions #1 and #2 implemented for Issue [READACTED TEXT] (failure to perform the reconciliation of test results) do not specifically address the root causes identified by the investigation and they do not describe the time frame for effectiveness checks (ECs) or actions to be taken when the ECs do not reflect the required improvements. In addition, these Corrective Actions were not completed within the designated timeframes.

Download the pdf file to read the complete inspection report.