Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. |
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
DISTRICT OFFICE ADDRESS AND PHONE NUMBER
6000 Metro Drive, Suite 101
Baltimore, Maryland 21215 |
DATE(S) OF INSPECTION:4/22 - 12/20/02 |
FEI NUMBER:1000123507 |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO:Ramesh Thadani, Executive Vice President and
Chief Executive Officer |
FIRM
NAME
American National Red Cross/Biomedical Services |
STREET
ADDRESS
1616 Fort Myer Drive |
CITY,
STATE AND ZIP CODE
Arlington, Virginia 22209 |
TYPE OF
ESTABLISHMENT INSPECTED
National Headquarters of a Licensed Blood Bank |
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: INADEQUATE INVESTIGATION OF EMPLOYEE ALLEGATIONS OF
SIGNIFICANT RECORDKEEPING IRREGULARITIES:
Biomedical Headquarters (BHQ) has failed to properly evaluate all employee allegations of
significant record keeping irregularities and take corrective action to prevent
recurrence.
- On 10/6/00, the Vice President of Quality Assurance (QA) submitted a potential system
problem. The records of the system problem indicate the issue was non-concurrent
documentation and falsification of records-cases have been identified
On
10/16/00, this issue was assigned system problem # 511. On 3/27/01, the system problem was
closed by the Chief Operating Officer as being isolated instances not meeting
the definition of a system problem. The cases reviewed involved four reports from National
Testing Laboratories (NTLs) and eight reports from the ARC regions. Examples are as
follows: following the erroneous release of two plasma products in one region, one
employee reported being asked to sign as a second reviewer for a shipment she had not
physically counted and that employees were cutting corners to increase the
amount of product packed. Another region reported that an employee took the health history
from the donor, failed to document the reason for deferral of the donor and then discarded
the health history record when the reason for deferral could not be recalled.
- After closure of the system problem #511 and without BHQ taking any system-wide
corrective action allegations of significant record keeping irregularities continued to be
received. From December 2001 to January 2002, there were at least three reports of records
not reflecting the actual work performed or non concurrent record keeping in the NTLs:
- In December 2001, a report from one NTL stated that 28 products had been labeled with
hemoglobin S results although no test results were recorded on the testing worksheet. This
worksheet was also reviewed and signed by two other employees including quality control
staff. The report indicates that the quality assurance officer in the NTL stated there was
a culture to hide problems and there is a pervasive attitude that the
staff can clean problems up so they can never be found.
- In January 2002, an employee in an NTL reported that another employee over
incubated the antibody plates but had not recorded the correct times on the
worksheet. The investigation revealed the employee who witnessed the problem had
reported a similar incident to the supervisor; however, that incident was not investigated
at the time. The employee reported fearing retaliation if she was seen reporting a problem
to the supervisor.
- In January 2002, the records indicate there was an Investigation of Falsification
of NAT Test Records. During that investigation, one employee reported that
verification is to be performed concurrently when possible but due to staffing
levels workload, this does not always occur.
A special audit was
conducted in August 2001 when the regions management notified regional QA of a
possible falsification of records. The report states The fact that only
the cumulative loss records were altered would have an affect on donor safety and not
product quality. All staff interviewed verified they found documents which
were
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SEE REVERSE OF THIS PAGE |
EMPLOYEE(S) SIGNATURE
[Handwritten] Mary T. Carden
Linda S. Mattingly
Stephany J. Wesley |
EMPLOYEE(S)
NAME AND TITLE [Handwritten]
Mary T. Carden, Investigator
Linda S. Mattingly, Investigator
Stephany J. Wesley, Investigator |
DATE ISSUED
12/20/02 |
FORM FDA 483 (8/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL
OBSERVATIONS
Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: "Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy of such report
shall be sent promptly to the Secretary." |
Web page created by ORA Web Team 12/20/2002
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