Inspections, Compliance, Enforcement, and Criminal Investigations
Lone Star Lions Eye Bank 12/12/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
December 12, 2011
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Michael A. Wilson, President
Board of Directors
Lone Star Lions Eye Bank, Inc.
102 East Wheeler Street
Manor, Texas 78653
Dear Mr. Wilson:
The Food and Drug Administration (FDA) conducted an inspection of your firm located at 102 East Wheeler Street, Manor, Texas between July 20 and July 25, 2011. During the inspection, our investigator identified significant 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, Parts 1271 (21 CFR 1271), issued under the authority of Section 361 of the Public Health Service Act (42 USC 264).
At the close of the inspection, a Form FDA-483 was presented to and discussed with Ms. Bess Beliveaux, Executive Director. The items of concern include, but are not limited to the following:
1. Failure to retain the records pertaining to a particular HCT/P at least 10 years after the date of its administration, or if the date of administration is not known, then at least 10 years after the date of the HCT/P's distribution, disposition, or expiration, whichever is latest as required by 21 CFR 1271.55(d)(4).
Specifically, your firm failed to retain records used to determine donor eligibility. Your firm continues to discard medical records and records obtained from other sources once donor eligibility has been completed and recorded on the Donor History Worksheet. We note this observation was brought to the attention of Ms. Beliveaux during the previous inspection conducted October 1 to October 7, 2009.
We acknowledge receipt of your firm's response letter dated August 31, 2011 provided by Ms. Beliveaux, Executive Director, to FDA's inspectional observations. We have reviewed the response and found it inadequate to address our concerns. The Agency has stated that 21 CFR 1271.55 would require that the establishment that made the eligibility determination, maintain the records for at least 10 years and make them available for FDA inspection.
2. Failure to properly establish procedures for all steps performed in the manufacture of HCT/Ps as required by 21 CFR 1271.270(b).
a. SOP D1.000 "Donor Eligibility Criteria - Policy" fails to require retention of all records used in determining eligibility for the required 10 years. Step 3 of the procedure states copies of medical records may be discarded after relevant information for the determination of eligibility has been obtained and recorded on the Donor History Worksheet.
b. SOP M1.000 "Eye Bank Records"- fails to require retention of all records used in determining eligibility for the required 10 years. The SOP states under "M1.100 Length Of Storage - Policy" the FDA regulations require retention of records for a minimum of ten years after the date of transplantation/implantation, distribution or whichever is longer. However, the SOP goes on to state that copies of medical charts and other such copies of "non-required" records that are available from other agencies, hospitals, and/or institutions may be purged from the donor chart once donor eligibility has been determined and tissues have been distributed.
The deviations identified above are not intended to be an all-inclusive list of the deficiencies at your facility. It is your responsibility to ensure that your establishment complies with all applicable requirements of federal regulations. You are responsible for reviewing your firm's operations to assure you are in compliance with all applicable FDA regulatory requirements. You should take prompt action without further notice. Failure to do so may result in additional regulatory action. Such action may include, but is not limited to, an order to retain, recall, destroy or cease manufacture of HCT/Ps.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter, with further details of the specific steps you have taken to correct the noted deviation and to prevent its recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your response should be sent to the Food and Drug Administration, Dallas District Officer, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204, to the attention of Elvia J. Cervantes, Compliance Officer. Should you have any questions concerning this letter, you can contact Elvia Cervantes at (214) 253-5236.
Reynaldo R. Rodriguez, Jr.
Dallas District Director