Johns Hopkins Hospital Blood Bank Warning July
May 30, 2003
RETURN RECEIPT REQUESTED
Ronald R. Peterson, President
Johns Hopkins Hospital and Health Care Systems
600 N. Wolf Street
Baltimore, Maryland 21287
Dear Mr. Peterson,
The Food and Drug Administration (FDA) conducted an inspection
of your blood bank facility located at 600 N. Wolf Street,
Baltimore, Maryland, on February 3-6, 10, and 25, 2003. The
inspection revealed numerous deviations from the Good Manufacturing
Practice (GMP) regulations, Title 21, Code of Federal Regulations
(CFR), Parts 210, 211 and 606. These deviations cause your
facility to be in violation of Section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act (the Act).
The deviations observed included:
Failure to observe, standardize,
and calibrate equipment on a regularly scheduled basis to
assure that it will perform in the manner for which it as
designed, in that incubation time and temperature, agitation
speed, and time for the [redacted] and [redacted], and [redacted]
and the [redacted] which are components of the [redacted]
have not been qualified. [21 CFR 211.68 and 606.60(a)]
Failure to perform a thorough
investigation and make record of the conclusions and follow-up
of unexplained discrepancy. Specifically, quality control
investigations of discrepancies associate with the [redacted]
system did not determine the cause of the discrepancies and
no corrective actions were implemented to prevent recurrence.
[21 CFR 606.100(c)]
Failure to maintain written
standard operating procedures (SOPS) including all steps to
be followed in the compatibility testing of blood and blood
components for homologous transfusion. Specifically, your
blood bank lacks written SOPs for steps taken when the [redacted]
system procedures results that are inconsistent with patient
history; and when the [redacted] system is unable to interpret
antibody screening results. [21 CFR 606.100(b(8)]
Failure to submit a biological
product deviation report. Specifically, blood documented on
[redacted] Report Forms" were not reported to FDA as
required. [21 CFR 606.171]
The above deficiencies are not intended to be-an all-inclusive
list of deficiencies at your blood bank facility. It is your
responsibility to ensure that your blood bank facility is
in compliance with all applicable requirements of 21 CFR Parts
210-211, Parts 600-680, and the Act.
You should take prompt action to correct these deviations.
Failure to promptly correct these deviations may result in
regulatory action by FDA without further notice. Such action
includes seizure and/or injunction.
We have received and reviewed your letter, dated April 16,
2003, regarding the FDA-483 issued at the conclusion of the
February 2003 inspection. Our evaluation of your response
follows, and is numbered to correspond to the items listed
on the Form 483:
Observation 1: The response is inadequate, in that the "validation"
data lacks specific details regarding the steps taken to qualify
the equipment. For example, your response indicated that the
incubation of the [redacted] instruments was performed for
[redacted] minutes. However, there was no data or information
regarding the assessment of the incubation temperature for
the intended use of the equipment. Additionally, how were
the times for the incubator assessed? Also, your response
noted "target" and "actual" times for
the incubator and [redacted] shaker. However, there was no
indication as to how the measurements were taken.
Observation 2: The response is inadequate. While your firm
implemented immediate corrective action to address the problems
in your manufacturing procedures, you did not address your
failure to thoroughly investigate unexplained discrepancies,
including follow-up and conclusions.
Observation 3: The response appears to be adequate.
Observation 4: The response appears to be adequate.
Observation 5: While your firm promised to submit biological
product deviation reports to FDA, there was no indication
of the corrective measures implemented, if any, to keep the
problem from recurring.
We request that you notify this office in writing, within
fifteen (15) working days of receipt of this letter, of the
specific steps you have taken to correct the noted deviations
and to prevent their recurrence. Your response should include
examples of documentation showing that corrections have been
achieved. If corrective action can not be completed within
15 working days, state the reason for the delay and the time
within which corrections will be completed.
Your reply should be directed to Vinetta Howard-King, Compliance
Officer, U.S. Food and Drug Administration, 6000 Metro Drive,
Suite 101, Baltimore, Maryland 21228. If you have any questions,
please do not hesitate to contact Ms. Howard-King at (410)
779-5454, extension 413.
Director, Baltimore District