Inspection of Military Blood Establishments (6/18/92) Date June 18, 1992 From Director, Division of Field Investigations (HFC-130) Subject Inspection of Military Blood Establishments, Revised instructions for Command Notification To Investigations Branch Directors Info: District Directors Regional Food and Drug Directors Mr. Chesemore's memorandum of May 6, 1992 gave instructions for the transfer of 30 licensed military blood banks to the field inventory. This memorandum modifies the military headquarters notification procedures and provides interim instructions for compliance procedures. Districts should now notify the military of approaching inspections directly and do not need to go through CBER. Contacts for the three branches of the military, which operate licensed blood bank locations, are attached. The headquarters command of the respective military branch should be notified about two weeks before an inspection to allow a check for operations affecting the inspection such as war games. These military contacts will be included in the Contacts for Other Federal Agencies in Part VI of compliance program 7342.001, Inspection of Licensed and Unlicensed Blood Banks when it When deviations from the regulations are encountered during the inspection of a military blood bank, issue the FDA 483 to the most responsible individual on site. Send a copy of the FDA 483 to the Responsible Head of that military establishment and to the Office of Compliance, Division of Inspections and Surveillance, Biological Product Inspection Branch (HFB-122.) An example of a post inspection letter for a military blood bank is attached. Military blood banks must meet the same safety and quality standards as civilian blood banks. If deviations indicate immediate action is needed or if reinspection demonstrates adequate corrective actions have not been taken, notify the Division of Case Management (HFB-110) as soon as possible to determine if the violations warrant issuance of a Warning Letter or other action. Please inform the Division of Field Investigations (HFC-130) of such cases too. Please continue to assure experienced, well-qualified investigators with significant blood banking experience are assigned to these inspections. Robert C. Fish _________________________________________________ LOCATION ESTABLISHMENT LICENSE NO. Wright Peterson, OHUSAF Medical Center 610-003 Orlando,FL Naval Hospital 635-007 Jacksonville, FL Naval Hospital 635-017 Keesler AFB, MSUSAF Medical Center 610-005 Ft. Polk, LA US Army Hospital 611-022 Ft. Knox, KY US Army Hospital 611-008 Millington, TN Naval Hospital 635-008 Travis AFB, CA USAF Medical Center 610-002 San Francisco, CA Letterman Army Med Ctr 611-009 Ft. Ord, CA Armed Services BB 611-012 Camp Pendleton, CA Naval Hospital 635-003 Long Beach, CA Naval Hospital 635-005 San Diego, CA Naval Hospital 635-001 Charleston, SC Naval Hospital 635-016 Beaufort, SC Naval Hospital 635-012 Ft. Carson, CO US Army Hospital 611-015 Aurora, CO US Army Hospital 611-003 Colorado Springs, CO USAF (Academy) Hospital 610-009 Ft. Leonard Wood, MO US Army Hospital 611-014 Ft. Riley, KS US Army Hospital 611-016 Portsmouth, VA Naval Hospital 635-002 Lackland AFB, TX USAF Medical Center 610-001 Ft. Sam Houston, TX US Army Hospital 611-001 Newport, RI Naval Hospital 635-011 Ft. Dix, NJ US Army Hospital 611-011 Philadelphia, PA Naval Hospital 635-015 Honolulu, HI US Army Hospital 611-006 Minot AFB, ND USAF Medical Center 610-010 Ft. McClellan, AL US Army Hospital 611-020 Tacoma, WA US Army Hospital 611-007 COMPLIANCE PROGRAM 7342.001 CONTACTS FOR OTHER FEDERAL AGENCIES Veterans Administration Hospitals E.M. Travers, M.D. Director of Pathology Services, Symbol #111F Department of Medicine and Surgery Veterans Administration 810 Vermont Avenue, N.W. Washington, DC 20420 8-535-7075 Comm: 202-535-7075 Indian Health Service Hospitals Linda Meacher Division of Research Coordination Indian Health Service Parklawn Building 5600 Fishers Lane Rockville, MD 20857 8-443-4680 Military contacts (Districts should notify military contacts directly, at least 30 days in advance of the inspection.) Lt. Colonel Suellyn Novak, Air Force, 202-767-5054 Lt. Colonel Robert Pick, Army, 703-756-0153 or Lt. Colonel Richard Brown, Army, 703-756-4611 Commander Bruce Rutherford, Navy, 202-653-1086 Responsible Heads for Military Lt. General Alexander M. Sloan Department of the Air Force HQ USAF-SGHR Bolling AFB, DC 20332 Vice Admiral D.F. Hagan Department of the Navy Bureau of Medicine and Surgery, MED-OO Washington, DC 20372-5120 Lt. Gen. Frank F. Ledford, Jr. Department of the Army 5 Skyline Place, Attn: HQDA (SGPS-CP-L) 5109 Leesburg Pike Falls Church, VA 22401-3258 __________________________________________ CENTER FOR BIOLOGICS EVALUATION AND RESEARCH PROGRAM CONTACTS General Compliance Matters, Imports, Exports, Inspections, Samples, Complaints, Product Defects, Errors and Accidents, Fatalities, Viral Marker Testing, Computer Issues, GMP Guidance: Office of Compliance, Division of Inspections and Surveillance, HFB-120 Boyd Fogle, Jr., Director. Telephone: FTS 295-8191 or 301-295-8191 Contact Persons within Biological Product Inspections Branch, HFB-122 (FTS 295-8191 or 301-295-8191), for questions pertaining to: Margaret A. Tart, Chief Viral Marker Testing: Cathy Conn or Sharon O'Callaghan Fatalities: Mary Ann Tourault Errors & Accidents: Sharon O'Callaghan or Janet Ishimoto Contact persons within Surveillance and Policy Branch, HFB-124 (FTS 295-8191 or 301-295-8191), for questions pertaining to: Fred Blumenschein, Chief Imports & Exports: Fred Rangel or Kim Migliore Product Defect Reports & Consumer Complaints: Jerome Davis Compliance Programs & CPG's: Fred Rangel Computer Issues: Alice Godziemski Case Guidance, Warning Letters, Legal Actions, License Revocations, Suspension of Operations Under License, Recalls Office of Compliance, Division of Case Management, HFB-110 Steven Masiello, Director Telephone: FTS 295-8185 or 301-295-8185 Case Guidance Branch, HFB-114 Emilie Sanborn, Chief Recalls and Administrative Actions Branch, HFB-112 Chief - vacant Consumer Affairs Representative Division of Congressional and Public Affairs, HFB-140 Congressional, Consumer and International Affairs Branch Chief - vacant Telephone: FTS 295-8228 or 301-295-8228 Licensing and Labeling of Products, Variances; Approvals for Changes in Personnel, Location, Off-site Storage, Manufacturing Methods, Registration, etc. Division of Product Certification, HFB-240 Blood Products and Diagnostics Branch Mary Gustafson, Chief Telephone: FTS 295-8428 or 301-295-8428 Contact persons within DPC for questions pertaining to: Blood bank licensing issues: Linda Amendt or Karan Repsher Registration: Barbara Coates SOP's, Donor Medical History Forms, AIDS Educational Materials, Consent Forms, and Technical Information Relating to Blood Products Office of Biologics Research Division of Transfusion-Science Ann Hoppe, Acting Director Laboratory of Blood Bank Practices, HFB-940 Telephone: 301-227-6487 or FTS 394-6487 0RA C0NTACT ORA/ORO/DFI Investigations Operations Branch, HFC-132 Telephone: FTS 443-3340 or 301-443-3340 ________________________________________________________ Compliance Program 7342.001 Attachment I Rear Admiral Robert Higgins (NAME AND ADDRESS OF RESPONSIBLE HEAD) Department of the Navy Bureau of Medicine and Surgery Washington, D.C. 20372-5120 Dear Admiral Higgins: : An inspection of the U.S. Naval Hospital located at TOWN, STATE on DATE revealed deviations from Title 21, Code of Federal Regulations. At the conclusion of the inspection, the inspector discussed these deviations with NAME & RANK/TITLE OF PERSON RECEIVING THE FDA-483 and OTHERS PRESENT AT THE CLOSEOUT provided them with a written list of these observations. A copy of this document, Form FDA-483, is enclosed. Please advise us, in writing, of your actions to correct the deviations noted, within 30 days of receipt of this letter, in sufficient detail to permit us to determine compliance with the regulatory standards. Sincerely yours, DISTRICT DIRECTOR CC: HFB-120 Attachment ______________________________________________ DATE: June 12, 1992 FROM: Chief, Surveillance and Policy Branch (HFB-124)/ Division of Inspections and Surveillance/Office of Compliance/ Center for Biologics Evaluation and Research SUBJECT: Notification of Reported Change - For Your Information Type of Change: Signature Representative, US License 0610 TO: Director, Investigations Branch (SAN-DO/HFR-PA150) 1. Due to the pending retirement of Colonel Albert B. Briccetti, the new signature representative for Lieutenant General Alexander M. Sloan, Surgeon General; pursuant to the Code of Federal Regulations, Title 21, part 601.12(a) is: Peter F. Hoffman, Colonel, USAF, MC Associate Director, Medical Plans and Resources Office of the Surgeon General 2. Questions and correspondence may be directed to the Surgeon General through the blood program office, HQ USAF/SGHR, Attention: Lt Col Suellyn W. Novak, Bolling AFB DC 20332-6188, (202) 767-5054. Frederick U. Blumenschein __________________________________________________ DEPARTMENT OF THE AIR FORCE HEADQUARTER UNITED STATES AIR FORCE BOLLING AFB DC 20332-6188 February 25, 1992 SUBJECT: Change In tho Signature Representative, US License 610 TO: Director, Division of Product Certification Center for Biologics Evaluation & Research/HFB-240 Food and Drug Administration 8800 Rockville Pike Bethesda MD 20892 1. Due to the pending retirement of Colonel Albert B. Briccetti, my new signature representative pursuant to the Code of Federal Regulations, Title 21, part 601.12(a) is: Peter F. Hoffman, Colonel, USAF, MC Associate Director, Medical Plans and Resources Office of the Surgeon General 2. Questions or correspondence may be directed to me through our blood program office, HQ USAF/SGHR, Attention: Lt Col Suellyn W. Novak, Bolling AFB DC 20332-6188, (202) 767-5054. ALEXANDER M. SLOAN Lieutenant General, USAF, MC Surgeon General The information submitted herewith has been noted and filed with your license application. This notification constitutes official acknowledgment Linda Amendt 3/3/92 Div. Prod. Certification Center for Biologics Evaluation and Research