Inova Health Care Services, Inova Blood Donor Services 5/3/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455Fax: (410) 779-5705
CMS # 298919
May 3, 2012
Return Receipt Requested
Mr. Mark S. Stauder, President and COO
Inova Health System, Governance Affairs
8110 Gatehouse Road, Suite 200 East Tower
Falls Church, VA 22042
Dear Mr. Stauder:
During the inspection of Inova Blood Donor Services located at 45745 Nokes Boulevard, Suite 160, Sterling, VA 20166, conducted by the Food and Drug Administration (FDA) between January 23 and February 13, 2012, our investigators documented numerous significant violations of the Current Good Manufacturing Practice (CGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations
(CFR), Parts 600-680. These violations cause your blood and blood products to be adulterated within the meaning of Section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act (FD&C Act), 21 USC § 351(a)(2)(B). (You may find the Act and FDA regulations through links in FDA’s home page at www.fda.gov
.) The violations include, but are not limited to, the following:
1. Each donor was not in good health as indicated in part by systolic and diastolic blood pressures which were not within normal limits and the examining physician was not determining that individuals with blood pressures outside these limits were otherwise qualified as donors. [21 CFR § 640.3(b)(2)] Specifically, the documented blood pressure for donor (b)(6) was 184/77 on the Medical History Form (MHF) for the January 24, 2012 donation of Whole Blood Unit (b)(6). According to Standard Operating Procedure (SOP) IBS 03-101, Donor Screening, Revised 09/21/11, the donor would be ineligible to donate, yet the donor was accepted to donate a unit of whole blood. The Leukocyte Reduced Red Blood Cell product manufactured from this unit was distributed on January 31, 2012. [FDA-483 observation 1.F.]
2. Failure to calibrate equipment used in the compatibility testing, storage, and distribution of blood and blood components on a regularly scheduled basis as prescribed in the SOP Manual to assure that it performs in the manner for which it was designed. [21 CFR § 606.60(a)] Specifically,
a. A review of the calendar year 2011 maintenance logs for the infectious disease equipment, (b)(4), which are utilized to test blood donor samples for anti-HIV 1/2, Hepatitis C and Chagas disease, revealed that weekly maintenance was not being performed as required by the manufacture of the equipment and SOP IBS 07-605, (b)(4), Revised 02/01/07. [FDA-483 observation 2.A.] For example:
i. Weekly maintenance was performed on October 22, 2011 and not again until November 7, 2011, 16 days later.
ii. Weekly maintenance was performed on June 20, 2011 and not again until July 4, 2011, 14 days later.
iii. Weekly maintenance was performed on October 20, 2011 and not again until November 6, 2011, 17 days later.
b. A review of the calendar year 2011 maintenance logs for the infectious disease equipment, (b)(4), which is the nucleic acid test system utilized to test blood donor samples for HIV 1, Hepatitis B, Hepatitis C and West Nile, revealed that the weekly maintenance was not being performed as required by the manufacture of the equipment and in SOP IBS 07-728, (b)(4), Effective 8/3/10. [FDA-483 observation 2.B.] For example:
i. Weekly maintenance for the Shutdown and Restart System was performed on October 3, 2011 and not again until October 15, 2011, 12 days later.
ii. Weekly maintenance for the mag wash cleaning was performed 10 days apart between January 11 - 21, 2011 and October 31 - November 10, 2011.
c. A review of the calendar year 2011 maintenance logs for the infectious disease equipment, (b)(4), which is the automated pipetter utilized for nucleic acid testing on the (b)(4), revealed that the weekly maintenance was not performed as required by the manufacture of the equipment and in SOP IBS 07-726, (b)(6), Effective 3/11/09, Revised 6/9/10, which specifies that weekly maintenance is to be performed at the end of each week or after 40 hours of operations. For example, weekly maintenance was performed on April 20, 2011 and not again until May 7, 2011, 17 days later. [FDA-483 observation 2.C.]
d. A review of the calendar year 2011 maintenance logs for the infectious disease equipment, (b)(4), which is utilized to test blood donor samples for HBsAg, HBc, and HTLV 1/2, revealed that the weekly and bi-weekly maintenance was not performed as required by the manufacture of the equipment and in SOP IBS 07-121, (b)(4), Revised 9/26/08. [FDA-483 observation 2.D.] For example:
i. The July 2011 log documented that weekly maintenance was conducted on July 13, 2011 and July 22, 2011, 9 and 8 days apart, respectively. The log also documented that bi-weekly maintenance was conducted on July 6, 201 and July 22, 2011, 16 days apart.
ii. The April 2011 log documented that bi-weekly maintenance was conducted on April 6, 2011 and April 28, 2011, 22 days apart.
3. Failure to report to FDA events and information relevant to events associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of both licensed and unlicensed blood or blood components. [21 CFR § 606.171(b)] The FDA investigators discovered that two reportable events were not reported to FDA. [FDA 483 observation 3] Specifically, Biological Product Deviation Reports (BPDRs) were not submitted for the following deviations:
a. It was discovered on March 9, 2011, that the last bi-weekly maintenance in the month of February 2011 was not performed on the (b)(4), the instrument utilized to test blood donor samples for ABO and syphilis. The FDA investigators identified three units of blood products that were distributed outside your licensed firm between the time the last bi-weekly maintenance, performed on February 19, 2011, and the date the deviation was discovered on March 9, 2011.
b. It was discovered on November 16, 2011 that the weekly maintenance was not performed on the two (b)(4), which are utilized to test blood donor samples for anti-HIV 1/2, Hepatitis C and Chagas, during the periods of October 22 through November 7, 2011 and October 20 through November 6, 2011. The FDA investigators identified three units of blood products that were distributed outside your licensed firm between the time of the last weekly maintenance, performed on October 20, 2011, and the date this deviation was discovered on November 7, 2011.
4. Failure to establish and maintain written standard operating procedures which include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion. [21 CFR § § 606.100(b)(9), 606.100(b)] Specifically:
a. SOP IBS 01-992, Donor Reaction Audits, Revised 8/23/11, and SOP IBS 03-113, Dealing with Donor Reactions, Revised 9/15/10, did not include clear instructions for investigating, documenting and maintaining donor adverse reactions. Additionally, the SOPs failed to provide instructions on how post donation donor adverse reaction reports or “complaints” are investigated, documented and maintained. According to the Donor Advocate, these types of reports are post donation adverse reaction calls received by the firm directly and/or through the Inova Blood Donor Services confidential exclusion phone line. FDA investigators reviewed approximately 500 Donor Adverse Reaction Reports from October 2010 through January 2012 which revealed missing or incomplete information. [FDA 483 observation 5] For example:
i. Approximately 101 of the Donor Adverse Reaction Reports were not being reviewed by the Donor Advocate and/or quality assurance representative.
ii. The section of the Donor Adverse Report with the heading “Please Provide A Brief And Factual Description of What Happened” was not being completed for several reports at the collection sites.
b. The written procedures for HCV Lookback investigations found in SOP IBS 01-948A, Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Tests for HCV 3.0, HTLV-I/II, HBV, ANTI-HBC, HIV 1/2, HIV NAT, HCV NAT, and T. cruzi Antibody, did not include the procedure currently being performed for HCV Lookback investigations. [FDA 483 observation 6]
c. SOP IBS 07-605, (b)(4), Revised 02-01-07, did not specifically address the (b)(4) User’s Guide guidance that weekly maintenance is required to be performed at the end of day seven before shutdown or at the beginning of day eight prior to use. [FDA 483 observation 6]
5. Failure to maintain records concurrently 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)(1), 606.160(a)(2)] For example:
a. A review of the (b)(4) Daily, Weekly, Bi-weekly and Monthly Maintenance Logs for calendar year 2011 revealed that the daily and shut-down sections were not being documented completely as required in SOP IBS 07-121, (b)(4), Revised 9/26/08, and the (b)(4) Operations Manual. [FDA 483 observation 7]
b. The identity of the lot numbers for the blood collection bags was not recorded in such a way as to identify which blood collection bag is used to collect blood and blood products from each donor. Additionally, SOP IBS 03-116, Final Review/Charge Nurse Review and Batch Control, Effective 9/9/10, requires “For Whole Blood, verify that bag type and lot number in the appropriate box on the Medical History Form.” Yet, the MHFs currently in use, since December 5, 2011, had no area to record the lot number of the blood collection bags. [FDA-483 observation 8]
We have received your correspondence dated March 15, 2012, submitted in response to the FDA-483, Inspectional Observations; it will be made part of our official files. We have reviewed your response and find the corrective actions, in general, to be isolated to the observations on the FDA-483. However, this response does not address the underlying causes of the deviations. Your response did not include sufficient information to enable us to assess whether your firm has effectively implemented its proposed corrective actions or whether those corrective actions will adequately address the underlying causes of the deviations described above.
The deviations identified above are not intended to be an all-inclusive list of deficiencies at your establishment. It is your responsibility to ensure that all products marketed by your firm comply with the FD&C Act and its implementing regulations. You must take prompt action to correct these violations. Failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice including, but not limited to, seizure, injunction, and/or prosecution.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence. Please include all documentation of the corrective actions you have taken. If all corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response must be sent to Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, Baltimore District, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, contact Ms. Honeycutt at (410) 779-5412.
Director, Baltimore District
Cc: Ms. Terri L. Craddock, Director
Inova Blood Donor Services at Dulles Town Center
45745 Nokes Blvd., Suite 160
Sterling, VA 20166