Inspections, Compliance, Enforcement, and Criminal Investigations
Houchin Blood Services 21-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|San Francisco District |
1431 Harbor Bay Parkway
Alarneda, CA 94502-7070
Via Federal Express
Our Reference: 2974534
September 21, 2005
Greg Gallion, CEO
Houchin Blood Services
5901 Truxton Avenue
Bakersfield, CA 93309
Dear Mr. Gallion:
The Food and Drug Administration (FDA) conducted an inspection at your licensed blood bank facility, Houchin Blood Services (HBS) located at 2600 G Street, Bakersfield, CA 93301 from June 13 through June 17, 2005. The inspection revealed significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for Blood and Blood Components, Title 21, Code of Federal Regulations (CFR), Part 606 and other regulations for biologics [21 CFR 600-680]. These deviations cause your blood products to be adulterated within the meaning of Section 501(a}(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The deviations documented on the Form FDA-483 issued and discussed with you at the conclusion of the inspection included:
1. Your facility failed to follow the manufacturer's instructions when performing confirmatory tests on blood and blood components [21 CFR 606.65(e)].
Specifically, your facility has a contract with another blood bank to perform testing. This contracted blood bank in turn has a contract with another laboratory for testing of HIV Western Blot and HTLV confirmatory tests. This laboratory utilizes the [redacted] Genetic Systems HIV-1 Western Blot assay, for which the instructions for use states that the serum or plasma may be stored up to seven days at 2-8C. The storage conditions during storage and transit of the blood samples can not be determined. For example, a blood sample (#[redacted] from Donor [redacted]) was drawn on 2/16/2004. The date the sample was received at the contract laboratory was 2/27/2004. A final report was processed on 2/28/2004. This time frame exceeds the seven day storage period. There is no documentation of the exact conditions at which sample are maintained, and the specimens are not maintained frozen. The manufacturer's instructions are not followed, test results are accepted and donors are re-entered based on these test results.
2. a) Your facility failed to take appropriate action when,a donor tests repeatedly reactive for antibody to human immunodeficiency virus (HIV') as required by "Lookback" requirements [21 CFR 610.46(a)(1)]. Specifically,
i) Consignees are not notified within 72 hours of a repeat reactive HIV result for purposes of quarantine;
ii) Consignees are not notified of all products, only in-date products;
iii) A twelve month lookback is performed from the repeat reactive test result instead of the last non-reactive test result.
For example: Donor [redacted] tested HIV repeat reactive on 6/5/2004 (unit [redacted]),
The donor's prior lookback donations include:
Unit [redacted] donated on 3/14/2003, which consisted of a RBC unit
Unit [redacted] donated on 10/4/2002, which consisted of a RBC unit
Unit [redacted] donated on 3/22/02, which consisted of a washed cell
Lookback notification for unit [redacted] did not occur until 6/17/2004. Lookback notification was not initiated for units [redacted] and [redacted]
b) Your facility lacks written procedures in accordance with 21 CFR 610.46 to look at prior donations of Whole Blood, blood components, Source Plasma, and Source Leukocytes, when a donor of blood. subsequently tests repeatedly reactive for antibody to HIV, or otherwise is determined to be unsuitable when tested in accordance with the applicable regulations [21 CFR 606.100(b)(19)].
Specifically, your facility's Standard Operating Procedure"(SOP) OP109/11 -"Overview and Management of Donors with Abnormal Laboratory Test Interpretation Re: Product/Deferral/Notification" is not consistent with regulations in that your SOP states:
i) Quarantine and destruction is performed for in-date components only;
ii) The recovered plasma contractor is to be notified 'Within 5 days instead of 72 hours;
iii) Within one week of notification of a positive confirmatory test interpretation, identify and arrange for quarantine and discard of all in-date components; the performance of quarantine and discard extends back 12 months prior to the donor's last negative test result.
3. Your facility failed to maintain written standard operating procedures describing the criteria used to determine donor suitability, including acceptable medical history criteria [21 CFR 606.100(b)(1)]. Specifically, there are no specifc procedures established for the re-entry protocols for donors who have tested repeat reactive for HIV 1/2, HCV, HBsAg and HBc.
4. Your facility failed to make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation [21 CFR 630.6(c)]. For example, Donor [redacted] tested repeat reactive for HIV on 8/13/2004; Western Blot negative on 8/23/2004. The first notification occurred on 8/23/2004; the second notification occurred on 9/23/2004 and the third notification occurred on 11/29/2004, which is approximately 14 weeks after the confirmatory test results. Also noted during the inspection was that your facility failed to document that you had successfully notified this deferred donor.
The above deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all applicable regulations. You should take prompt action to correct these violations. Failure to correct these violations may result in administrative and/or regulatory action without further notice. Such action includes license suspension and /or revocation, seizure and/or injunction.
FDA received your July 18, 2005 response to the FDA 483, Inspectional Observations that the FDA investigator had issued at the conclusion of the recent inspection of your firm. We have completed our review of your response and have determined that your response is inadequate to address all the above violations that FDA documented at your firm. Our evaluation follows and is numbered to correspond to the items as they appeared on the FDA 483 and in your response:
Item 1: The response is inadequate to address the noted observation. The proposed corrective action does not reference what steps you will take to monitor your contract blood bank, but only addresses record review of the contract laboratory confirmatory testing to ensure sample validity was met. Also, it does not address what action you will take if the donor is not available when retesting is necessary. For future tests, the specific sample integrity requirements which would be incorporated into your proposed implementation of acceptance criteria were not indicated.
Item 2: The response is inadequate to address the noted observation. The proposed corrective action does not address the specific steps of how promptly your facility would implement the quarantine and notify consignees to comply with the lookback requirements. Written procedures must be in accordance with 21 CFR 610.46.
Item 3: The response is inadequate to address the noted observation. The proposed corrective action does not address whether or not your facility would maintain written standard operating procedures and the specific steps your facility will follow, including the criteria used to determine donor suitability at your facility.
Item 4: The response is inadequate to address the noted observation. You have not stated the specific actions you will take to ensure the problem will not recur.
We request that you notify this office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations, including examples of any documentation showing that corrections have been achieved. If you cannot complete all the corrections before you respond, please explain the reason for your delay and the date by which each item will be corrected and documented.
Please send your reply to the Food and Drug Administration, Attention: Juliane K. Jung-Lau, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Ms. Jung-Lau at (510) 337-6793.
Barbara J. Cassens
San Francisco District Director