|Company:||LifeSouth Community Blood Centers, Inc.|
|Subject:||CGMP for Blood & Blood Products/Adulterated|
|Issuer:||New Orleans District Office|
|Issued:||Jan. 30, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (616) 366-7802
January 30, 2012
WARNING LETTER NO. 2012-NOL-12
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Nancy E. Eckert
President and CEO
LifeSouth Community Blood Centers, Inc.
4039 Newberry Road
Gainesville, Florida 32607
Dear Ms. Ecke1t:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2801 WestCorp Boulevard SW, Huntsville, Alabama 35805, from October 17 through November 14, 2011. During the inspections, FDA investigators documented deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations (21 CFR) Parts 606 and 640. These deviations caused your blood.and blood products to be adulterated "'Within the meaning of section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act (the Act), 21 USC§ 351(a)(2)(B). These deviations include but are not limited to the following:
1. Failure to store and maintain Red Blood Cells (RBC) at a temperature between 1°C and 6°C immediately after processing [21 CFR 640.11(a)]. On multiple occasions between May 6, 2011 and July 8) 2011, Cooler #1 and Cooler #5 exceeded the acceptable temperature range. For example, from 11:15 PM on July 5, 2011, to 2:30 PM on July 7, 2011, Cooler #5 was out of the acceptable temperature range of 1°C to 6° C. The temperature was recorded between 9.25°C and 10.59°C and there was no record of products being moved to an appropriate alternative storage location.
2. Failure to maintain storage and distribution records. [21 CFR 606.160(b)(3)(i)]. Records were not always maintained that document the status of blood components in your (b)(4) System (b)(4) . Your firm has failed to maintain discard records from September 2010 to the present. Your Technical Communication Announcement (#2010-09:07), instructs the staff to discontinue the use of Manual Discard Record forms, with the implementation of (b)(4) . However, the system cannot identify discarded units because your firm has not established a computer source code to retrieve this data. No records have been maintained or can be retrieved through the (b)(4) system in order to document all discarded blood components. For example:
a. On June 20, 2011, an (b)(4) report was initiated because the plasma component for unit (b)(4) could not be labeled, as the RBC component for which was not accounted. As of November 1, 2011, the final disposition of the RBC was not documented.
b. On February 8, 2011, an (b)(4) Problem Report was initiated for the following (b)(4) components that had been physically discarded, but whose documentation of the final disposition in (b)(4) was missing:
3. Failure to maintain distribution records which contain information to readily facilitate the identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s), and the date of expiration or the date of collection, whichever is applicable [21 CFR 606.165(b)]. On December 20, 2010, you shipped (b)(4) Red Blood Cell units (b)(4) to (b)(4) . On or around January 29, 2011, (b)(4) returned the same RBC units as part of stock rotation. On February 4, 2011, you contacted (b)(4) to perform an inventory check and discovered our courier picked up the RBC units on December 21, 2010 from (b)(4) and delivered them to (b)(4) .Your firm did not document the transfer in (b)(4) until February 11, 2011.
4. Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer [21 CFR 606.65(e)]. Storage temperatures for quality control reagents and blood collection supplies are not monitored and controlled, as required by the manufacturers' instructions.
Specifically, the manufacturer's recommended storage temperatures for the following reagents and supplies are: 15°C to 30°C for the (b)(4) 10°C to 25°C for the pH 4 and pH 10 buffers; and 4°C to 25°C for blood collection tubes. However, your firm does not monitor the temperatures of the locations where these supplies and reagents are stored.
5. Failure to review all records pertinent to the lot or unit before the release or distribution of a lot or unit of final product (21 CFR 606.100(c)]. The review, or portions of the review, was not performed at appropriate periods during or after blood collecting, processing, compatibility testing and storing. Specifically, you failed to insure the proper storage conditions and irradiation requirements were met. The following irradiated units were distributed prior to review of the "Documentation of Irradiation" form:
a. Apheresis Platelets units were (b)(4) were irradiated and distributed on January 5, 2011; however, the review did not take place until February 18, 2011.
b. Red Blood Cells unit
was irradiated and distributed on January 13, 2011; however, the review did not take place until February 18, 2011.
c. Red Blood Cells units (b)(4) were irradiated and distributed on January 17, 2011; however, the review did not take place until February 18, 2011.
d. Red Blood Cells units (b)(4) were irradiated and distributed on March 17, 2011; however, the review did not take place until April 7, 2011.
6, Failure to make and record a thorough investigation, including the conclusions and follow-up, of any unexplained discrepancy, or the failure of a lot or unit to meet any of its specifications 21 CFR 606.100(c)]. For example, on August 12, 2011, Red Blood Cells unit (b)(4) was returned by a consignee due to (b)(4) . Upon return of the unit, you failed to quarantine the unit and initiate an investigation. On August 20, 2011, the unit was distributed to the same consignee and transfused.
7. Failure of the personnel responsible for the collection, processing, compatibility testing, storage or distribution of blood or blood components to have adequate training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess [21 CFR 606.20(b)).
On October 17, 2011, our investigators observed a component technician processing an antibody-positive RBC unit (b)(4) .The component technician failed to follow the firm's procedure, "Handle Components from Reactive Donations" (CPM6.1). The technician failed to attach an antibody tag to the unit and Label it as required by the procedure. The same technician failed to follow procedure "Hold and Quarantine Components" (CPM.1.1), because a quarantine sticker was placed on the outer protective covering of the Fresh Frozen Plasma instead of on the actual unit.
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 all requirements of the federal regulations.
We acknowledge receipt of your written response dated November 17, 2011, which addresses the inspectional observations on the Form FDA 483 issued on November 14, 2011. Your response is inadequate because it failed to address corrective actions implemented for all the deviations noted in the FDA 483 and instead addressed only those observations related to the tornado disaster. In addition, your response did not provide sufficient details or proposed completion dates to fully assess the adequacy of your corrective actions.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in administrative or regulatory action by the FDA without further notice, including, but not limited to, seizure and/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 or will take to correct the noted violations including an explanation of how you will prevent their recurrence. If the corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your response should be sent to the attention of Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. Ms. Batey may be reached at (615) 366-7808.
Patricia K. Schafer
New Orleans District
Enclosure: Form FDA 483
Letter dated November 17,2011