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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Envita Natural Medical Centers of America 14-Jun-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville MD 20852-1448




By Certified Mail - Return Receipt Requested And by Facsimile Transmission

CBER - 06 -- 006

JUN 14 2006

Warning Letter


Mr. Dino Prato
Office Administrator
Envita Natural Medical Centers of America
8759 East Bell Road
Scottsdale, Arizona 85260

Dear Mr. Prato:

This letter describes the results of a Food and Drug Administration (FDA) inspection conducted on March 1, 2006. FDA Investigator Dr. Sandra L. Shire met with you to review the conduct of studies at Envita Natural Medical Centers of America (Envita). FDA conducted this inspection under the Bioresearch Monitoring Program that includes inspections designed to review the conduct of research involving investigational products.

The inspection revealed that Envita manufactures a product using a Standard Operating Procedure for Establishment of Long-Term 4NKT Cultures. The product is administered to individuals to treat a variety of illnesses, including various cancers, as referred to in your document entitled "Informed Consent to Receive 4NKT":

"Possible Benefits . . .Today's current research is focusing on natural killer (NK) cell immunotherapy because of their ability to kill tumor cells that have spread from the original diseased site."

The manufacturing process invloves the [redacted] of [redacted] and [redacted] to [redacted] cells (cells). The cell cultures are incubated for a period of [redacted] days to [redacted] days to before being re-administered to subjects (treated cell cultures). The bears the description "Products are for research use only. Not for use in diagnostic or therapeutic procedures. "[redacted] is also not approved for these uses.

Based on this information, we have determined that your treated cell cultures violate the Public Health Service Act (PHS Act) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The treated cell cultures are a biological product as defined in section 351(i) of the PHS Act [42 U.S.C. § 262(i)], in that they are a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product, or arsphenamine or derivative of arsphenamine, applicable to the prevention, treatment, or cure of a disease or condition of human beings . The treated cell cultures are also a drug within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)], in that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.

In order to introduce or deliver for introduction a biological product into interstate commerce, a valid biologics license (BLA) or new drug application (NDA) must be in effect [21 U.S .C. § 355(a) ; 42 U.S.C. § 262(a)]. A BLA or NDA is issued only after a showing of safety, purity and potency (for a BLA) or safety and effectiveness (for an NDA) for the product's intended use. Before approval, biological products and drug products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect [21 U.S.C. § 355(i) ; 21 CFR Part 312; 21 CFR 601.21]. Your treated cell cultures are not the subject of an approved BLA or NDA, and you do not have an IND in effect.

Your treated cell cultures do meet the definition of human cells, tissues, and cellular and tissue-based products (HCT/P). Under 21 CFR Part 1271, HCT/Ps are not subject to license or IND requirements if certain criteria are met. However, these criteria are not met here. An IND application is required for the treated cell cultures because the cells are more than minimally manipulated, as provided for under 21 CFR § 1271.10(a)(1).

In addition, you violated regulations governing the proper conduct of clinical studies involving INDs, specifically, the failure to submit an IND application to the FDA, the failure to withhold administration of an IND until an IND application is in effect, in violation of 21 CFR §§ 312.20(a) and (b), as well as the failure to meet the general requirements for use of an IND in a clinical investigation, in violation of 21 CFR § 312.40(a).

Furthermore, the treated cell cultures appear to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because their labeling fails to bear adequate directions for use for the purposes for which the drug is intended.

This letter is not intended to contain an all-inclusive list of deficiencies. It is your responsibility to ensure adherence to each requirement of the law and applicable regulations, and to protect the rights, safety, and welfare of subjects under your care.

You should notify this office, in writing, within fifteen (15) business days of receipt of this letter of the steps you plan to implement to prevent the recurrence of similar violations in future studies. Your response should include any documentation necessary to show that correction has been achieved.

You may submit an IND application to the FDA pursuant to Title 21 CFR Part 312. If an IND application is submitted, no clinical investigation is permitted to proceed until the IND application is in effect, as described in 21 CFR §§ 312.20 and 312.40. These regulations are available at http://www.gpoaccess.gov/cfr/index.html).

Information to assist you in submitting an IND application is available at http://www fda gov/cber/ind/ind htm. Questions regarding submission of an IND application and assistance may be directed to the FDA's Center for Biologics Evaluation and Research Office of Communications, Training, and Manufacturers Assistance at (800) 835-4709.

This Warning Letter is issued to you because of the serious nature of the observations noted at the time of the FDA inspection . Please be advised that failure to implement effective corrective actions and/or the commission of further violations may result in the initiation of enforcement action(s) without further notice . These actions could include injunction and initiation of clinical investigator disqualification proceedings, which may render you ineligible to receive investigational drugs.

Please send your written response to:
Christine J. Drabick
Dvision of Inspections and Surveillance (HFM-664)
Office of complaince and Biologics Quality
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, Maryland, 20852-1448
Telephone: (301) 827-6323

We request that you send a copy of your response to the FDA District Office listed below.

Sincerely,

/s/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research