Inspections, Compliance, Enforcement, and Criminal Investigations
Blood Bank of the Redwoods 04-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|San Francisco District |
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Via Federal Express
October 4, 2005
Our Reference: 2970085
Cathy C. Bryan, President and CEO
Blood Bank of the Redwoods
2324 Bethards Drive
Santa Rosa, CA 95405
Dear Ms. Bryan:
The Food and Drug Administration (FDA) conducted an inspection at your licensed blood bank facility, Blood Bank of the Redwoods, 2324 Bethards Drive, Santa Rosa, CA from July 11 through 15, 2005. The inspection revealed significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for Blood and Blood Components, Title 2l , 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) [21 U.S.C. 351(a)(2)(B)]. The deviations documented on the Form FDA-483 issued and discussed with you at the conclusion of the inspection included:
1. Failure to notify consignees of the results of the licensed, more specific test for HIV (Western Blot) within 30 calendar days after the donor's repeatedly reactive test as
required by 21 CFR 610.46(b). You are required to notify consignees of whole blood, blood components, source plasma, and source leukocytes collected from a donor within 5 years prior to the repeatedly reactive test. Specifically, you failed to notify the consignees of the Western Blot results for units [redacted] and [redacted]. In addition, you failed to notify the consignee of unit [redacted] of the repeated reactive HIV screening test results with in 72 hours as required by 21 CFR 610.45(a)(ii).
2. Failure 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 as required by 21 CFR 630.6(c). Specifically, you did not document that you left a message for the donor or that the donor received written notification until approximately 11 weeks after the donor was deferred for unit [redacted].
3. Failure to have quality control procedures and follow those procedures for periodic tests of capacity of shipping containers to maintain proper temperature in transit as required by 21 CFR 606.160(b)(5)(iv).
4. Failure of personnel to have training and experience, including professional training as necessary, to assure competent performance of their assigned functions as required by 21 CFR 606.20(b). Specifically, employees [redacted] and [redacted] trained personnel on procedures prior to themselves receiving training on those specific procedures.
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 August 15, 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:
Items 1.a), l.b) and l.c): The response is inadequate to address the noted observation. The previous two inspections conducted January 2001 and May 2003 found deficiencies in your lookback and notification procedures and practices. Your firm's Compliance Officer responded to the May 2003 inspection on May 30 and June 30, 2003. In those responses she promised to correct the deficiencies in the HIV Lookback and notification procedures and practices. The current inspection found the same or similar problems in the HIV Lookback and notification system. FDA will verify that you have adequately implemented your corrective actions during our next inspection.
Item 3: The response is inadequate to address the noted observation. The proposed corrective action discusses that the annual QC of the coolers will simulate a mobile drive, however your response fails to provide measurable parameters, such as length of time in cooler and environmental temperatures, which can be verified to simulate actual use conditions.
Item 4: The updated procedure appears to address the deficiency, however, the implementation of the corrective action will be verified during FDA's next inspection.
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: Russell A. Campbell, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Mr. Campbell at 510-337-6861.
Barbara J. Cassens
San Francisco District