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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Coulston Foundation 11-Oct-01


Public Health Service

Food and Drug Administration
Rockville MD 20857

October 11, 2001
Ref. No.: 01-HFD-45-1001

Frederick Coulston, Ph.D.
CEO, Chairman of the Board
Coulston Foundation
1300 La Velle Road
Alamogordo, New Mexico 88310

Dear Dr. Coulston:

Between July 26 and August 19, 1999, and between November 27 and December 8, 2000, investigators from the Food and Drug Administration (FDA) inspected the non-clinical laboratory facilities of the Coulston Foundation to assess adherence to the Good Laboratory Practice (GLP) regulations, Title 21, Code of Federal Regulations, Part 58. These inspections were conducted as part of the FDA's Bioresearch Monitoring Program which includes inspections designed to monitor the conduct of research involving investigational products.

The year 2000 inspection was a result of inadequate responses to some of the deficiencies raised in a Warning Letter dated December 22, 1999, and your failure to request a reinspection of your facility. As a result of that inspection, the agency has determined that the Coulston Foundation has not corrected all the deficiencies raised in the December 22, 1999, Warning Letter. Specifically, from the items cited at the first of the inspections referenced above items #1.2, #7, and #23 were not adequately addressed in correspondence after the original inspection and items #1, #7, #9, #10, #12, #20.1, and #23 were found to be repeated upon re-inspection. With regard to the second inspection, your responses dated March 28, 2001, and July 16, 2001, did not address several items satisfactorily (i.e., #3.0, #4.0, #5.1-5.9, #5.11-5.13, #5.17-5.19, #5.21-5.25, #5.27, #7.1, #7.3, #11.0, #13.0, #14.0, #16.0, and #17.2).

Further, the Coulston Foundation initiated the following non-clinical laboratory studies after receipt of the subject letter that specifically warned not to start any new studies:

Study # [redacted] Collection of Muscle Tissue from Chimpanzees Following Intramuscular Administration of [redacted] The final report, before amendment, states hat the study was conducted in accordance with the FDA Good Laboratory Practice regulations currently in effect (21 CFR 58).].

Study # [redacted] A 12 Month [redacted] Efficacy study with HBV Challenged Chimpanzees [The protocol states that this is both a safety and an efficacy study.]

Study # [redacted] Subcutaneous Safety/PK/Immunogenicity Study in Chimpanzees

Study # [redacted] Single Dose PK and Safety Study in Rhesus Monkeys, [redacted]

Study # [redacted] Evaluation of the Safety and Efficacy of a Candidate [redacted] Vaccine in Chimpanzees

In the December 22, 1999, Warning Letter the agency stated that of any further new non-clinical laboratory studies, the observed Good Laboratory Practice (GLP) deficiencies must be corrected, and that you should request reinspection from the FDA's Denver District Office. The agency also stated that it may refuse to consider any particular non-clinical laboratory in support of an application for a research or marketing permit, if it finds that the study was not conducted in accordance with the GLP regulations.

Because the Coulston Foundation has not corrected all the deficiencies raised in the above referenced Warning Letter we are recommending to the FDA product evaluation staffs that any non-clinical laboratory study that has been initiated since the receipt of the Warning Letter should not be considered in support of an application for a research or marketing permit in accordance with 21 CFR 58.215(b).

In addition, the study #[redacted] that was inspected during the last inspection had numerous deviations from the GLP regulations. These objectionable conditions compromised the study as to make it not reliable for review of drug safety. We are recommending to the FDA product evaluation staffs that under the provisions of 21 CFR 58.215 (b), this study # [redacted] entitled A 12-Month Repeated Nasogastric Incubation Study of [redacted] Followed by a 4-Week Recovery Period in Male and Female Cynomolgus Monkeys, should not be considered in support of an application for a research or marketing permit.

The recommendation for the rejection of these studies is in addition to any actions that the FDA may take under 21 CFR 58.206 or 21 CFR 58.215 (a).

Within fifteen (15) working days after receipt of this letter, you should send to this office a written corrective action plan for the outstanding deficiencies, with one element of the plan being a time line for your commitment to a completion date of the corrective actions. We ask that you include with this plan a statement of what are the Coulston Foundation's intentions to continue to operate as a non-clinical testing facility.

Failure to promptly correct these violations and prevent future violations may result in regulatory action without further notice. These actions may include proposal for the disqualification of your facility and/or appropriate judicial proceeding (civil or criminal) and other appropriate regulatory action and/or referral to another government law enforcement or regulatory agency.

We invite you to schedule a meeting at FDA headquarters by contacting Mr. Anthony E. Rodgers, Acting Deputy Director, Division of Scientific Investigations Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Place, HFD-45, Metro Park North I, Room 102, Rockville, Maryland 20855, Telephone (301) 827-5460, FAX (301) 594-1204 to discuss your plans for correcting the outstanding deficiencies.

Coulston Foundation has the right to be advised and represented by counsel at all times.

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