Inspections, Compliance, Enforcement, and Criminal Investigations
LifeServe Blood Center 8/9/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
August 9, 2013
RETURN RECEIPT REQUESTED
Ref. – 2013-14
Stacy L. Sime, President/CEO
LifeServe Blood Center
431 E Locust St
Des Moines, IA 50309-1909 US
Des Moines, IA 50309-1909 US
Dear Ms. Sime:
The Food and Drug Administration (FDA) conducted an inspection at your licensed blood bank, LifeServe Blood Center, located at 431 E. Locust St., Des Moines, IA 50309-1909, between June 13 and 27, 2013. During the inspection, our investigator documented significant deviations from applicable FDA regulations for current Good Manufacturing Practice (cGMP) for blood and blood components, Title 21, Code of Federal Regulations, Parts 21 CFR Part 606 and 610. Such deviations cause your blood products, manufactured, processed, packed, or held at this facility, to be adulterated within the meaning of section 501(a)(2)(B) [21 USC 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act). The following deviations, observed by our investigator during the inspection:
1. Failure to test blood and blood components for evidence of infection due to communicable disease agents in accordance with manufacturer’s instructions [21 CFR 610.40(b)]. Specifically, on January 17, 2012, the mini-pool samples for unit # (b)(7)(c); (b)(6), and (b)(7)(c); (b)(6) tested reactive using the (b)(4) system: (b)(4) Nucleic Acid Testing (NAT). In addition;
a. On January 18, 2012, the NAT resolution sample for unit (b)(7)(c); (b)(6) tested individually reactive.
b. On January 19, 2012, the NAT resolution samples for units (b)(7)(c); (b)(6) and (b)(7)(c); (b)(6) tested individually reactive.
c. On January 19, 2012, reactive NAT sample tubes for units (b)(7)(c); (b)(6), (b)(7)(c); (b)(6) and (b)(7)(c); (b)(6) were sent to a contract laboratory for (b)(4) Discriminatory testing.
d. On January 25, 2012, contract laboratory test results for Nucleic Acid Testing- Human Immunodeficiency Virus type 1 (HIV-1) (NATH), Nucleic Acid Testing-Hepatitis C Virus (NATC), and Nucleic Acid Testing-Hepatitis B Virus (NATB) were all unresolved.
e. On February 8, 2012, (b)(4) sample tubes for (b)(7)(c); (b)(6), (b)(7)(c); (b)(6), and (b)(7)(c); (b)(6) were tested once on the (b)(4) system: (b)(4). The results were non-reactive, and these results were used as the test of record.
You followed the package insert for the (b)(4) system: (b)(4) to the point the individual specimens were found to be reactive and the samples were sent to further testing (discriminatory testing). When the discriminatory test results were reported as, “Unresolved,” you accepted the non-reactive (b)(4) results from the (b)(4) samples and inappropriately invalidated the initial tests of record when those results met test package insert acceptance criteria. In lieu of an established, written procedure, you neither followed the package insert or the Guidance for Industry Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type1(HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry : May 2010, as you claim in your response to the FDA 483, dated July 11, 2013. You misinterpreted the NAT Algorithms on page 6 of the Guidance for Industry Nucleic Acid Testing for Human Immunodeficiency Virus Type -1(HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry May 2010, referenced in your letter dated July 11, 2013, The discrepant testing results the Blood Product Advisory Committee (BPAC) was referring to in the guidance document was between the initial mini-pool and the individual resolution testing results. Both the initial multiplex mini-pool and individual resolution samples for the three units were “reactive”.
Although you suspected cross contamination from the true positive donor during specimen preparation or sample loading, you cannot invalidate the reactive mini-pool (b)(4) and the individual reactive resolution NAT testing results, since the controls on each batch were valid. This was confirmed by the manufacturer during your investigation.
Your letter, dated July 11, 2013, is inadequate because you did not acknowledge your failure to test these samples in accordance with the manufacturer’s instructions. Your letter states you accepted donors with discriminatory test results of “Unresolved” as if they were “Non-reactive” or “Negative,” rather than deferring the donors for six months and possible re-entry.
2. Failure to defer future donations of human blood and blood components from donors testing reactive by a screening test for evidence of infection due to a communicable disease agent listed in 21 CFR 610.40(a) [21 CFR 610.41(a)] and failure to restrict from use human blood and blood components collected from a donor with a previous record of a reactive screening test for evidence of infection due to a communicable disease agent [21 CFR 610.40(h)(1)]. Donors # (b)(7)(c); (b)(6), (b)(7)(c); (b)(6) and (b)(7)(c); (b)(6) initially tested reactive for mini-pool (b)(4) and the individual resolution NAT testing performed on January 18, 2012 and January 19, 2012. These donors should have been deferred until successful re-entry.
a. Donor (b)(7)(c); (b)(6) was accepted for donation and collected on the following dates: (b)(7)(c); (b)(6) unit (b)(7)(c); (b)(6), (b)(7)(c); (b)(6) unit (b)(7)(c); (b)(6), (b)(7)(c); (b)(6) unit (b)(7)(c); (b)(6), (b)(7)(c); (b)(6) unit (b)(7)(c); (b)(6).
b. Donor (b)(7)(c); (b)(6) was accepted for donation and collected on (b)(7)(c); (b)(6) unit (b)(7)(c); (b)(6).
c. Donor (b)(7)(c); (b)(6) was accepted for donation and collected on (b)(7)(c); (b)(6) unit (b)(7)(c); (b)(6).
Blood products from these above units were distributed.
Your letter, dated July 11, 2013, is inadequate because you did not acknowledge your failure to defer these donors until such time as they could be re-qualified by a method acceptable to the FDA. In your response you concluded that based on your investigation, these three donors were eligible to donate since the test results were invalid due to contamination and that the donors did not need to be deferred and put through the donor re-entry program. The results of your investigation of the suspected contamination, including the retesting of a second sample collected at the time of donation, should have been used as supporting documentation for the re-entry of these donors. The NAT testing results of the mini-pool (b)(4) and individual resolution tests were reactive and considered as the initial tests of record and should not have been invalidated.
3. Failure to concurrently maintain records with the performance of each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components so that all steps can be clearly traced (21 CFR 606.160(a). From December 6, 2011 through January 10, 2013, thirty seven ( 37) units of blood and blood components were discarded as “Status Unknown” from your firm’s inventory system. The following units were included:
o 11 platelet units
o 3 whole blood units
o 2 red blood cell units
o 2 cryoprecipitate units
o 19 recovered/salvaged plasma units
Your letter, dated July 11, 2013, is inadequate because you did not provide dates for the implementation of your new procedures or evidence to support your statement that no units have been discarded for “status unknown” since the implementation.
The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of blood and blood components, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with federal regulations. You should take prompt action to correct these violations. Failure to correct these violations promptly may result in administrative and/or regulatory action by FDA without further notice including, but not limited to, seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receipt of this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your response should be sent to Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Dr., Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer, Jessica E. Hensley at 913-495-5183.
John W. Thorsky
Kansas City District Office