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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Memorial Blood Centers 14-Nov-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142


November 14, 2005

WARNING LETTER

Ref to MIN 06-15

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Donald C. Berglund
Chief Executive Officer
Memorial Blood Centers
2304 Park Avenue
Minneapolis, MN 55404-3712

Dear Mr. Berglund:

The Food and Drug Administration (FDA) conducted an inspection of Memorial Blood Centers (MBC) located at 2304 Park Avenue, Minneapolis, Minnesota, between June 6 and July 18, 2005. During the inspection, FDA investigators documented deviations from section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351(a)(2){B)j and Title 21, Code of Federal Regulations (21 CFR), Parts 210-211 and 600-680.

The violations documented include but are not limited to the following:

1. Failure to follow written standard operating procedures (SOPS) 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 [21 CFR 211.100(b) and 21 CFR 606.100(b)].

Specifically:

a. During February 2005, 51 out of [redacted] blood components that were returned to MBC were accepted without the required documentation. SOP HS410, titled "Receipt of Returned Units," requires verification of the unit number, hospital name, reason for return, and initials of the person packing the units on form CS80.2. This documentation was incomplete or missing for the 51 blood components.

b. Seven-day circular temperature recording charts, dated between March 9-30, 2005, for platelet incubator #6 were reviewed and signed, however, three charts were missing pen tracings, indicating the temperature recorder was not functioning properly. There was no documentation of irregularity in the recording charts, as required by SOP CL-03-003, titled "Temperature Recording Charts: Handling."

c. SOP MBCM616, titled "How to Perform an Annual Review for an SOP," requires an annual review of all SOPs to ensure they reflect current operations. A review of your SOPs noted 20 documents for which an annual review was not completed.

During donor screening, the FDA investigator directly observed the following:

d. A donor screener failed to follow SOP DID500, titled "Performing a Donor Health History", in that a donor was not asked about use of the medication "Acitretin (Soriatane)."

e. A donor screener failed to follow SOP DID500, titled "Performing a Donor Health History," in that only the drug's brand name was read, instead of the generic names of drugs listed on the donor questionnaire.

f. On four occasions, donor screeners allowed the donors to answer medical history questions before the entire question was read. SOP DID500, titled "Performing a Donor Health History," requires the screener to allow the donor sufficient time to answer each question completely.

g. On two occasions, a phlebotomist failed to ask the donors to state their full name and verify that the Donor Medical Record was for the respective donor, as required by SOP DC 101, titled "Blood Collection."

2 . Failure to perform a thorough investigation, including conclusions and follow-up, of any unexplained discrepancy or the failure of a lot or unit to meet any of its specifications, in that despite implementing a clot evaluation plan in 2003 of clotted blood and blood components, you failed to make a record of the conclusions and/or perform follow-up investigations of unexplained clotted blood and blood components that were documented on sixty (60) Biological Product Deviation Reports from July 1, 2003, to June 6, 2005 [21 CFR 606.100(c)].

3. Failure to conduct training in current good manufacturing practice on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them and have the necessary training and experience relating to individual products [21 CFR 211 .25(a) ; 600.10(b)]. In addition to the violations cited above that involve employees' failure to follow current good manufacturing practice (including the failure to follow SOPs, which CGMP requires), the following deficiencies in your employee training records are -evidence that your CGMP training is not sufficient:

a. Six employees had no documented CGMP training at all.

b. Employees who left questions blank on their "Six Month Staff Competency" tests were nonetheless graded 100%. Other tests were not scored at all.

c. One employee's "Donor ID Training Module Interview & Phlebotomy Skills Assessment Worksheet" had no signature in the final approval block (record dated 2/18/03). That same employee's "Annual cGMP Competency Assessment" dated 3/10/05 had no score, reviewer signature, or final approval.

The above violations 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 letter dated August 16, 2005, that provided a preliminary response to the inspectional observations. We have concerns with the significant deficiencies pertaining to your employees involved in determining donor suitability and the documentation of employee training that was noted during FDA's inspection. Your establishment admits to archiving the previous training SOP's but there was no explanation as to why this was replaced with the current unsystematic use of forms to document training and continuing performance.

In addition, you informed the FDA investigators that the positions of both the Quality and Regulatory Affairs and the Education and Training Directors were combined and the resulting responsibilities of the combined position given to one individual. Please provide your rationale for determining how the Quality and Regulatory Affairs and Education and Training programs can now be effectively managed by a single individual.

You should take prompt measures to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such action includes license suspension, and/or revocation, seizure or injunction.

Please notify this office in writing, within fifteen (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. 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 directed to Compliance Officer Jane E. Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District