| Public Health Service Food and Drug Administration |
| Denver District Office Building 20 - Denver Federal Center P.O. Box 25087 Denver, Colorado 80225-0087 TELEPHONE: 303-236-3000 |
Department of Health and Human ServicesApril 08, 2010
WARNING LETTER
VIA UPS
James E. Shmerling, DHA, FACHE
President and CEO
The Children's Hospital Association Transfusion Medicine Services
13123 East 16th Avenue, B-120
Aurora, CO 80045
Reference No.: DEN-10-10 WL
Dear Dr. Shmerling:
During an inspection of The Children's Hospital Association Transfusion Medicine Services, located at 13123 East 16th Avenue, Aurora, Colorado, conducted by the Food and Drug Administration (FDA) between January 13 and February 10, 2010, our investigators documented significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations (CFR), Parts 210-211 and 600-680. These deviations 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), and include, but are not limited to:
1) Failure to defer donors testing reactive by a screening test for evidence of infection due to a communicable disease agent [21 CFR 610.41 (a)]. For example:
a) On 10/07/2008, the donor of Whole Blood unit (b)(4) (b)(6) tested repeat reactive for the antibody to the hepatitis C virus (anti-HCV) and was temporarily deferred until 04/07/2009. On 09/28/2009, the donor's status was changed in the computer database to "Active" (eligible to donate), although the donor had not been found suitable to donate to donate through a requalification method.
b) On 12/4/2008, the donor of Whole Blood unit (b)(4) (b)(6) tested repeat reactive for the antibody to the hepatitis C virus (anti-HCV) and was temporarily deferred until 06/04/2009. On 11/09/2009 the donor's status was changed to "Active" (eligible to donate), although the donor had not been found suitable to donate through a requalification method.
2) Failure to have a record available from which unsuitable donors may be identified so that products from such individuals will not be distributed [21 CFR 606.160(e)]. For example:
a) During a review of your donor database, potential duplicate donor records were identified for donor (b)(4) (b)(6). The donor status was designated as "Permanently Deferred," with no reason given for deferral in one record and as "Active" (eligible to donate) in the other.
b) Donor (b)(6) was deferred on 04/30/2009 for receiving a tattoo, but the Defer-to-Date (DTD) was not entered into the donor's computer record and as of the date of the inspection, the donor's status remained as "Active."
c) During donor screening on 07/30/2009, donor (b)(6) reported living in (b)(6) between (b)(6) and a permanent deferral notation was placed in the donor's donation record. However, as of 02/01/2010, the donor's status was still designated as "Active" in the computer database.
3) Failure to place Whole Blood in temporary storage having sufficient refrigeration capacity to cool the blood continuously toward a temperature range between 1 and 10°C until arrival at the processing laboratory [21 CFR 640.4(h)]. For example, after collection at mobile sites, units of Whole Blood and blood components are stored at room temperature for up to 7.5 hours prior to transport to the blood bank. Five Whole Blood units collected at a mobile site on 01/14/2010 were observed to sit unrefrigerated prior to transport to the blood bank for periods of time ranging from 5 hours and 12 minutes to 7 hours and 32 minutes.
4) Failure to exercise appropriate controls over computer systems to assure that changes in records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example, employee (b)(6) who was not authorized to access donor records that were designated as confidential, was permitted to change the status of these donors from "Permanently Inactive" to "Active (Unavailable)" (active, but not available on the donor center call list).
5) Failure to maintain processing records including all relevant dates and times for component preparation [21 CFR 606.160(b)(2)(ii)]. For example, review of your Component Preparation Log showed:
a) There is no documentation on the Component Preparation Log of the time when twenty-two (22) Red Blood Cell units were placed in the refrigerator.
b) There is no documentation on the Component Preparation Log of the time when nineteen (19) Fresh Frozen Plasma units were placed in the freezer.
c) There is no documentation of each step in the processing of Whole Blood into leukoreduced packed Red Blood Cells and Fresh Frozen Plasma.
The violations cited in this letter 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 requirements of the federal regulations.
We acknowledge receipt of your written response to the Form FDA-483, Objectionable Conditions, dated February 25, 2010. In regard to your response to Observation 2 of the Form FDA-483, you state that records of donors that were cited in the Form FDA-483 have been audited to ensure that there are no donated products that are subject to recall and that these donors were placed in a Temporarily Inactive status, pending re-instatement. However, you did not address a plan to audit records of all donors who tested repeat reactive for communicable disease agents to ensure that no unsuitable products from these donors were distributed and that the donors have been assigned the appropriate deferral status in the database.
In regard to your responses to Observations 9 and 12 of the Form FDA-483, you indicate you took immediate action to permanently defer the donor cited in Observation 12 in accordance with the procedure you revised in response to Observation 9. However, you did not address a plan to ensure that all donors who gave health history information that should have resulted in either temporary or permanent deferral were assigned the appropriate deferral status in the database, and that unsuitable products were not subsequently collected and distributed from these donors.
We have reviewed the remainder of your response and have found it to be generally adequate to address our concerns. The adequacy of your corrective actions will be verified during a future inspection of your facility.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in administrative or regulatory action without further notice, including, seizure, and/or injunction. FDA may re-inspect to verify corrective actions have been completed.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the noted violations. Include an explanation of each step being taken to prevent the recurrence of the violations. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Your reply should be sent to the attention of Nancy G. Schmidt, Compliance Officer, at the address on the above letterhead. If you have questions regarding any issue in the letter,. please contact Ms. Schmidt at (303) 236-3046.
Sincerely,
/s/
H. Thomas Warwick, Jr.,
Denver District Director
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