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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ZLB Behring 24-Jan-06

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

Public Health Service
Food and Drug Administration

 

Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, KS 66214-3340
Telephone: (913) 752-2100



January 24, 2006

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Ref: KAN 2006-11

Mr. Peter Turner, President
ZLB Behring
1020 First Avenue
King of Prussia, PA 19406

Dear Mr. Turner:

On December 7 through 13, 2005, an FDA Investigator from this office conducted an inspection of ZLB Plasma Services, located at 3939 Leavenworth St., Omaha, Nebraska. This inspection revealed serious deviations from the current Good Manufacturing Practice (cGMP) regulations for Blood and Blood Components, Title 21, Code of Federal Regulations, Part 606 (21 CFR 606) and Additional Standards for Human Blood and Blood Products, 21 CFR Part 640. These deviations cause blood products manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (the Act). Deviations observed during the establishment inspection include, but are not limited to the following:

  • Failure to defer from donation unsuitable donors [21 CFR 640.63(a)], such as:

    >an unreliable donor
    >donors with an unexplained weight loss of more than ten pounds.

  • Failure to clean and/or maintain equipment used to determine donor suitability in accordance with your standard operating procedures. [21 CFR 606.60]

  • Failure to collect a sample of blood from each donor on the day of the first medical examination or plasmapheresis, whichever comes first. The sample is required for serum protein electrophoresis (SPE) and serological testing for syphylis (STS) testing. [21 CFR 640.65(b)(1)(i)]

  • Failure to properly complete and/or maintain required records, including documentation of dates and initials of those performing the work. [21 CFR 606.100]

The above deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all source plasma produced and issued by your plasmapheresis centers is in compliance with the Act and with the CGMP regulations. You should take prompt action to correct these deviations. Your failure to correct these deviations may result in regulatory action being taken by FDA without further notice. Possible actions include license suspension and/or revocation, seizure, and/or injunction.

Our office is in receipt of the letter dated January 11, 2006 and signed for on behalf of Jonathan B. Knowles, Senior Director, RA/QA addressing the steps you are taking to correct the deviations noted on the FDA 483 - Inspectional Observations issued at the close of the inspection on December 13, 2005. We have reviewed this response and find the corrective actions, in general, to be isolated to the specifics of the FDA 483. This response does not address the underlying causes of the violations which may include ineffective oversight of .personnel and record review. As such, your response does not provide assurance to our office that you have taken effective measures necessary to prevent recurrence of the deviations.

Please inform this office, in writing, within fifteen (15) working days of receiving this letter of any additional steps you are taking to correct these deviations. If the corrective actions are going to extend past fifteen days, please include in your response a detailed and specific timeline for the completion of your actions.

You should direct your reply to Nadine Nanko Johnson, Compliance Officer, at the above address.

John W. Thorsky
District Director
Kansas City District