St Mary's Hospital and Medical Center, Inc. 11/8/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
November 8, 2012
Ref: DEN-13-3 WL
VIA UPS OVERNIGHT MAIL
Michael J. McBride
President and Chief Executive Officer
St. Mary’s Hospital and Medical Center, Inc.
2635 North 7th Street
Grand Junction, Colorado 81501-8209
Dear Mr. McBride:
The Food and Drug Administration (FDA) conducted an inspection of your firm, St. Mary’s Hospital and Medical Center, located in Grand Junction, Colorado, from June 4 through June 15, 2012. During this inspection, the FDA investigator documented deviations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351] and Title 21, Code of Federal Regulations (21 CFR) Parts 606, 640 and 211. These deviations include, but are not limited to the following:
1. Your firm failed to ensure red blood cells shall be placed in storage and maintained at a temperature between 1 and 6°C as required by 21 CFR 640.11(a), compare to 21 CFR 640.2(c)(3).
Specifically, the Packing and Returning of Units Transported on (b)(4) log fails to document (b)(4) storage and transfusion of returned Red Blood Cells (RBC). For example:
1) On June 21, 2011, unit (b)(4) was returned as being out of range and transfused on June 21, 2011.
2) On December 16, 2011, unit (b)(4) was returned as being out of range and transfused on January 11, 2012.
3) On December 16, 2011, unit (b)(4) was returned as being out of range and transfused on January 18, 2012.
4) On December 18, 2011, unit (b)(4) was returned as being out of range and shipped to another establishment on January 4, 2012.
5) On December 18, 2011, unit (b)(4) was returned as being out of range and shipped to another establishment on January 4, 2012.
2. Your firm failed to maintain records concurrently with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced as required by 21 CFR 606.160(a). Specifically,
1) Your firm failed to complete storage record documentation on the Packing and Returning of Units Transported on (b)(4) log. A few examples include: on August 12, 2011 unit #(b)(4) and (b)(4); on September 10, 2011 unit #(b)(4) and unit # (b)(4); and on April 3, 2012 unit (b)(4) and unit (b)(4).
2) On April 3, 2011, the Packing and Returning of Units Transported on (b)(4) log shows unit# (b)(4) was returned without storage documentation; however, the unit was transfused on April 9, 2011.
3. Your firm failed to observe, standardize and calibrate equipment on a regularly scheduled basis as prescribed in the Standard Operating Procedures Manual as required by 606.60(a).
Specifically, the SOP for thermometer control states that thermometers are to be calibrated on (b)(4) basis and deemed acceptable if found to be within (b)(4) degree of the (b)(4) thermometer. Thermometers not meeting QC requirements are returned to the manufacturer or discarded. On March 6, 2012, thermometers #(b)(4) failed calibration. Thermometer (b)(4) was off 5 degrees; (b)(4) was off 3 degrees, and (b)(4) was off by 4 degrees. At the time of inspection all three thermometers were still in use.
4. The quality control unit failed to review all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product as required in 21 CFR 211.22(c).
Specifically, your (b)(4) QA Review SOP states that documentation used for the packing and return of units transported on (b)(4) should be routed to the QA coordinator on a (b)(4) basis. However, numerous Packing and Returning of Units Transported on (b)(4) logs were identified as having deviations involving shipping and storage temperatures, unit traceability, and lacking a (b)(4) quality review.
We acknowledge receipt of your written response dated July 2, 2012 which addresses the inspectional observations on the Form FDA-483 issued on June 15, 2012. Documentation included with your response only addressed corrective actions for your firm’s use of the (b)(4). Your response indicates revisions to procedures and forms for better traceability of units involved with (b)(4); however, the documentation was not included with your response. Also, your response is unclear on corrective actions to complete thermometer calibration testing.
The deviations 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 all applicable requirements of the federal regulations. You should take prompt action to correct these violations. Failure to correct these violations may result in administrative and/or regulatory action by the FDA without further notice, including but not limited to license suspension and /or revocation, seizure and/or injunction.
Please notify this office, in writing, within fifteen (15) working days of receipt of this letter and of the specific steps you have taken or will take to correct the noted violations, including examples of how you will prevent recurrence. If you cannot complete all the corrections before you respond, state the reason for the delay and the timeframe within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, Food and Drug Administration, P.O. Box 25087 (Bldg. 20, Denver Federal Center, 6th
Avenue and Kipling Street), Denver, CO 80225-0087. If you have any questions regarding any issue in this letter, please contact Ms. Pinney at (303) 236-3024 or via email at firstname.lastname@example.org
LaTonya M. Mitchell
Denver District Director