Inspections, Compliance, Enforcement, and Criminal Investigations
Cooley Dickinson Hospital, BBM 8/26/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
VIA FEDERAL EXPRESS
August 26, 2009
Cooley Dickinson Hospital
30 Locust Street
Northhampton, MA 01060
Dear Mr. Melin:
The Food and Drug Administration (FDA) conducted an inspection of your firm, Cooley Dickinson Hospital Blood Bank located in Northhampton, Massachusetts, from July 6 through July 20, 2009. During the inspection, the investigator documented deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood components, Title 21 Code of Federal Regulations (CFR) Parts 606-680 and current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR Part 211). 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)]. These deviations include, but are not limited to the following:
1. Failure to restrict use of blood and blood components that are collected from a donor with a previous record of a reactive screening test when tested for antibodies to Human T-lymphotropic virus, types I and 11 (anti-HTLV-IIII) as required by 21 CFR 610.40(h)(l).
Specifically, your firm issued a deferral letter on November 28, 2005 to the donor of unit (b) (6) who had two repeatedly reactive screening tests for anti-HTLV-1/11. The donor was determined to be indefinitely deferred from donating blood. However, the donor was allowed to donate on twelve occasions from January 5, 2006 to February 27, 2009. As a result, seven leukocyte reduced red blood cells units were transfused at your establishment and one unit was distributed for transfusion to another facility.
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, the donor of unit was not notified of repeat reactive screening test for antibodies to Human Immunodeficiency Virus, types 1 and 2 (anti HIV-1/2) and confirmatory HIV-1 Immunofluorescent Assay (HIV-1 IFA) indeterminate test results.
3. Failure to check input to and output from the computer or related systems of formulas or other records or data for accuracy as required by 21 CFR 211.68 (b).
Specifically, duplicate donor records were created when your firm changed from (b)(6) Computer System to (b)(4) Computer System on December 2, 2008. The duplicate donor records do not always agree regarding donor eligibility status. For example, the donor cited in Item 1 is assigned a (b)(4) donor identification number of (b)(6) and has an eligibility status of "indefinitely deferred". The same donor has a (b)(4) identification number of (b)(6) and has an eligibility status of "eligible".
4. Failure to maintain and/or follow written standard operating procedures (SOP's) that include all steps to be followed in the collection, processing, compatibility, testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes as required by 21 CFR 606.100(b).
Specifically, unit (b)(6) tested repeat reactive for antibodies to HIV 1/2 and indeterminate for HIV-1 IFA. The final disposition of the leukocytes reduced red blood cells and recovered plasma components processed from this unit were not documented in your firm's computer system and on the Blood Donation Record as required by SOP 3.4.3, titled "Managing Allogeneic Donors with Positive Infectious Disease Marker Tests".
5. Failure to defer a donor who tested reactive by a screening test for evidence of infection due to a communicable disease agent from future donations of human blood and blood components as required by 21 CFR 610.41 (a).
Specifically, a blood sample from the donor of whole blood unit (unit (b)(6) collected on May 29, 2008 tested repeatedly reactive for Hepatitis C Virus antibody (Anti HCV) screening test on June 3, 2008. You received confirmatory positive Recombinant Immuno Blot Assay (RIBA) and positive HCV-Nucleic Acid Testing (NAT) results for this donor on June 10, 2008. However during the current FDA inspection, this donor's eligibility status was listed as "eligible" in your (b)(4) Computer System.
6. Failure to maintain donor records as required by 21 CFR 606.160(b).
Specifically, deferral letters were sent to donors (b)(6) who tested reactive for Hepatitis B Core antibody (Anti-HBc), however, these donors could not be located in the (b)(4) and (b)(4) Computer Systems. In addition, donor (b)(6) original blood donation record could not be located.
The above identified deviations are not intended to be an all-inclusive list of deficiencies at your establishment. It is your responsibility to ensure that your establishment is in compliance with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to correct these deviations promptly may result in administrative and/or regulatory action by FDA without further notice.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken or will take to correct the noted violations and to prevent their recurrence. Include documentation of any corrective action you have taken. If corrective action 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 should be sent to: Karen Archdeacon, Food & Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Ms. Archdeacon at 781 596-7707.
In addition, we request a meeting with you, at your earliest convenience, to discuss the issues cited in this letter together with your proposed corrective actions. Please contact Ms. Archdeacon at the address above to schedule the meeting, to be held at FDA's Office of Enforcement, Rockville, MD, with representatives from the Center for Biologics Evaluation and Research, the Office of Enforcement, and the New England District.
John R. Marzilli
New England District