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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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American Histolabs, Inc. 29-Nov-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
Rockville, MD 20857

NOVEMBER 29, 2001
WARNING LETTER
Certified Mail
Return Receipt Requested
Reference No: 01-HFD-45-1101
 

Wha Suk Eum
President
American Histolabs, Inc.
7605-F Airpark Road
Gaithersburg, MD 20879
 

Dear Mrs. Euro:

In September 2000, investigators from FDA's Baltimore District office conducted an inspection at you facility to assess adherence to the Good Laboratory Practice (GLP) regulations, Title 21, Code of Federal Regulations (CFR), Part 58. The inspection covered your firm's activities as a histologic slide preparation service.

During the inspection, the FDA investigators found several departures from the GLP regulations. These findings were listed on an Inspectional observations form FDA-453 which was issued to you at the conclusion of the inspection. Vie have evaluated the report of this inspection and your response to FDA's request on February 6, 2001 for additional information and conclude that your firm failed to adhere to the GLP regulations. We emphasize that:

  1. you failed to assure that there was a quality assurance unit (QAU) as described in 52.35 [21 CFR 58.31(c)]
  2. We found that since you terminated your private QAU contract in September of 1998 you failed to assure QAU oversight during the preparation of histology slides for GLP studies. We acknowledge your comment that BioReliance Corporation (Rockville, MD) audits your facility every 1-2 months. Although a sponsor may perform QAU audits of their own studies, the general process audits performed by BioReliance do not fulfill the requirement for an in-process QAU inspection of each BioReliance GLP study that you conduct [21 CFR 58.35(b) (3)] . Furthermore, QAU audits performed by BioReliance of their own studies co not provide QAU oversight for studies by sponsors other than BioReliance. Your February 23, 2001 response indicating that personnel follow all applicable standard operating procedures does rot relieve you of the requirement to assure in-process QAU inspection of each GLP study that you conduct.
  3. you failed co maintain a copy of a master schedule sheet of all non-clinical laboratory studies conducted at the testing facility that contained all the elements required by the GLP regulations [21 CFR 58.35 (b)(l)].

Specifically, the revised master schedule submitted to FDA on February 23, 2001 fails to list the current status of the studies.

The above discussion of violations is not intended to be an all-inclusive list of deficiencies at your facility. Failure to correct these violations may result in regulatory action without further notice. You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps that you have taken to correct these violations for your future studies.

If you have any questions concerning these matters, please contact:

C.T. Viswanathan, Ph.D.
Associate Director, Bioequivalence
Chief, GLP & Bioequivalence Investigations Branch
Division of Scientific Investigations
Office of Medical Policy
Center for Drug Evaluation and Research
7520 Standish Place, Room 151
Rockville, MD 20855
Telephone: (301) 827-5460
 

Sincerely,
Joanne L. Rhoads, M.D., M.P.H.
Acting Director
Division of Scientific Investigations
Office of Medical Policy
Center for Drug Evaluation ad Research