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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tissue Bank International/The National Eye Bank Center 11/28/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217-1003
           
Telephone: 615-366-7801
Facsimile: 615-366-7802 

 

 
November 28, 2012
 
WARNING LETTER NO. 2013-NOL-04
 
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
John M. Garry, III, Executive Director
Tissue Banks International
1770 Moriah Woods Boulevard, Suite 18
Memphis, Tennessee 38117
 
Dear Mr. Garry:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Tissue Banks International, National Eye Bank Center (TBI/NEBC), located at 1770 Moriah Woods Boulevard, Suite 18, Memphis, Tennessee, from June 18 through June 20, 2012. During the inspection, an FDA investigator documented deviations from the regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) set forth in Title 21, Code of Federal Regulations, Part 1271 (21 CFR 1271) and issued under the authority of Section 361 of the Public Health Service Act (42 United States Code 264).  You may find the specific regulations through links on FDA’s Internet home page at http://www.fda.gov.
 
At the conclusion of our inspection, a FORM FDA 483, Inspectional Observations was presented and discussed with you. The items of concern include, but are not limited to, the following:
 
1.    Failure to validate and approve a process according to established procedures.  The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation [21 CFR 1271.230(a)].  Specifically, your firm has been processing corneas utilizing the (b)(4) procedure since 2006.  During the inspection, it was noted validation of the (b)(4) process was not initiated until May 13, 2012.   
 
2.    Failure to monitor environmental conditions where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents [21 CFR 1271.195(c)]. 

Specifically, your Standard Operating Procedure (SOP) “NEBC Environmental Sampling Plan” describes (b)(4) environmental monitoring in areas where HCT/P processing occurs. Your firm failed to conduct environmental monitoring in these areas during November 2011 and April 2012.   

3.  Failure to document and maintain records of all equipment maintenance, cleaning, sanitizing, calibration, and other activities performed, in accordance with this Section [21 CFR 1271.200(e)].  Specifically, your SOP entitled “(b)(4) Cleaning, Operation and Maintenance” requires a sterilization run to be repeated in the event a sterilization run is aborted, incomplete, or does not meet cycle requirements.  The SOP also requires (b)(4) testing at least (b)(4) with a biological indicator test kit.
 
a.    A review of your Sterilization Logs showed failed sterilization runs for the following dates: August 11, 2010; September 11, 2010; September 15, 2010; September 16, 2010; February 7, 2011; and, January 25, 2012.  There was no documentation to indicate that the failed sterilization runs were repeated in these instances.
 
b.    There was no documentation that Biological Indicator testing was conducted within the (b)(4) requirement on at least 14 different occasions.  The Biological Indicator Logs show missing results for the following weeks:  August 8 - 14, 2010; September 5 - 11, 2010; October 10 - 16, 2010; November 21 - 27, 2010; December 5 - 11, 2010; December 19 - 25, 2010; May 15 - 21, 2011; July 17 - 23, 2011; August 14 - 20, 2011; October 23 - 29, 2011; December 4 - 10, 2011; December 18 - 24, 2011; March 11 - 17, 2012; and, April 29 - May 5, 2012.
 
We acknowledge receipt of your written response, dated July 5, 2012, describing the corrective actions you have taken in response to FDA’s inspectional observations of your operations.  Your response states you will complete validation of the (b)(4) process by August 15, 2012.  We note your records, collected during the inspection, document pre and post-processing cultures positive for alpha hemolytic streptococcus (Donor (b)(6) on May 24, 2012). We request your response to this letter include the final validation report and your actions taken in response to the observed positive results and any other positive results encountered during the study.  Also, we found your response to be inadequate in addressing corrective actions to ensure (b)(4) environmental testing is conducted and documentation is obtained to demonstrate invalid testing was repeated.
 
We request you notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken, beyond your written response of July 5, 2012, to correct these violations and to prevent their recurrence. Your response should include examples of documentation showing that the corrections have been achieved.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your reply should be directed to Rebecca A. Asente, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, TN 37217-1003.  If you have questions, Ms. Asente may also be reached at (504) 832-1290 extension 1104.
                                                           
                                                                       
Sincerely,
/S/ 
Patricia K. Schafer
District Director
New Orleans District
 
 
cc: 
Timothy E. Askew, President/CEO
Tissue Banks International
815 Park Avenue
Baltimore, Maryland 21201
 
Todd R. Meinecke, Director, Network Quality Assurance
Tissue Banks International
815 Park Avenue
Baltimore, Maryland 21201
 
C. Randall Mills, Ph.D., Chair
Tissue Banks International
815 Park Avenue
Baltimore, Maryland 21201