Inspections, Compliance, Enforcement, and Criminal Investigations
Blood Center of New Jersey 15-Apr-08
Department of Health and Human Services
Public Health Service
April 15, 2008
RETURN RECEIPT REQUESTED
Ms. Tina Ilao
President & CEO
The Blood Center of New Jersey
45 S. Grove Street
East Orange, New Jersey 07018-4106
Dear Ms. Ilao:
During an inspection of The Blood Center of New Jersey, located at 45 S. Grove Street, East Orange, NJ, conducted between August 17 and December 27, 2007, our investigators documented numerous deviations from the applicable regulations for blood and blood components under Title 21, Code of Federal Regulations (21 CFR), Parts 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). These deviations include, but are not limited to, the following:
1) Your firm failed to maintain and follow standard operating procedures and methods for determining the suitability of a donor as a source of blood. [21CFR 606.100(b)]
a) There is no written procedure for contacting donors to obtain qualifying information that was omitted from the initial screening and determine donor suitability within 24 hours of donation.
b) Suitability of products collected from donors who report illness post donations not determined by established and documented criteria.
c) Personnel failed to follow standard operating procedures for determining the suitability of donors in the following instance:
Erroneous BCNJ donor identification numbers were recorded on donor registration cards. These donor identification numbers are to be identified in the DPDM computer system to access donor eligibility data.
2) Your firm failed to determine the suitability of a donor as a source of Whole Blood on the day of collection. [21 CFR 640.3(a)(1)] Specifically:
On at least three instances in July 2007, donors were contacted more than 24 hours post-donation regarding donor suitability questions that had not been determined on the day of donation; all three units were approved and released.
3) Thorough investigations, including a record of the conclusions and follow-up for unexplained discrepancies and/or failure of a lot or unit to meet any of its specifications were not conducted and recorded. [21 CFR606.100(c)] Specifically:
Supporting documentation could not be provided for a written investigation regarding technicians recording incorrect BCNJ donor identification numbers and/or social security number approximately 47 times between January 5 and February 12, 2007. SOP B2.003.002, Blood Donor Interview and DRC Processing, requires verification of the donor identification number or social security number in the
computer DPDM system in order to determine a donor's deferral status. Actions taken to correct the problem, other than counseling employees and trending, were not documented as part of the investigation.
4) Written standard operating procedures were not followed for the collection, processing, and distribution of blood and blood components for transfusion. [606.100(b)]
a. On at least six occasions, leukoreduced Red Blood Cells were distributed even though they did not meet the [redacted] red cell recovery criteria specified in your SOP G2.006, Quality Control of Leukoreduced Red Blood Cell and Whole Blood.
b. On at least three occasions, there was no review by the medical director or designee following reports by donors who sought medical treatment as specified in SOP B1.001, Adverse Donor Reaction Management Includes First Aid.
c. SOP B2,003.01, Blood Collection (Phlebotomy) Procedure, requires any needle manipulation to be recorded on the donor registration card and treated as if there is a hematoma. However, Post Reaction/injury Reports from donors indicated there were needle manipulations where there was a failure to apply ice and to provide aftercare instructions. In addition, the corresponding donor registration cards showed a failure to record the needle manipulations, hematoma aftercare instructions, etc.
5) Personnel responsible for the collection and processing of blood or blood components are not adequate in numbers or training to assure competent performance of their assigned functions (21 CFR 606.20). For example:
Between January and August 2007, 33 Biological Product Deviation Information forms completed for donor services errors identified the contributing factor/root cause as busy donor drives, rushed staff, or understaffing.
6) Your firm failed to submit biological product deviation reports (BPDR) within 45 days from the date the information was acquired suggesting a reportable event occurred.
[21 CFR 606.171]
a) No report was submitted to FDA for BPD # [redacted] discovered on May 4, 2006, until November 19, 2007.
b) 29 of 88 BPDRs submitted for 2006-2007 were reported more than 45 days from the date the reportable event was discovered. Of these 29 late reports, three were reported at more than 100 days and 17 were reported between 70-90 days after discovery. We note that FDA investigators have documented your firm's failure to submit timely BPDRs during three previous inspections (April 2003, August 2004, and July 2005).
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 your establishment is in compliance with the Act and its implementing regulations. You should take prompt action to correct these deviations. Failure to correct these deviations promptly may result in administrative and/or regulatory action by FDA without further notice including, but not limited to, seizure and/or injunction.
We have received and reviewed your correspondence dated January 14, 2008, submitted in response to the FDA-483, List of Inspectional Observations; it will be made part of our official files. 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. We also note in particular that your response does not indicate that you have implemented an SOP to address Item 5.b. of the FDA-483
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, including any 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.
Please send your response to Sarah A. Della Fave, Compliance Officer, U.S. Food and Drug Administration, New Jersey District, 10 Waterview Boulevard, 3rd Floor, Parsippany, NJ 07054. If you have any questions, you may contact Ms. Della Fave at (973) 331-4910.
Douglas I. Ellsworth
New Jersey District
cc &FDA-483: Ronald Viscuso, M.D.
Chairman of the Board of Trustees
The Blood Center of New Jersey
769 Northfield Avenue
West Orange, NJ 07052