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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Nutraceutical International Corporation 19-Jul-04

Department of Health and Human Services' logoDepartment 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
Telephone: 303-236-3000
FAX: 303-236-3100


July 19, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Frank W. Gay
CEO
Nutraceutical International Corporation
1400 Kearns Blvd., 2nd Floor
Park City, Utah 84060

Ref. #: DEN-04-12

Dear Mr. Gay:

Consumer Safety Officer Ricki Chase-Off conducted an inspection of your manufacturing facility at 2815 Industrial Drive, Ogden, Utah, on April 20-26, 2004. During that inspection, a sample of Solaray Brand Korean Ginseng capsules, 535 mg, lot #080803, along with raw material ginseng lot #28195, were collected, Our analysis of the capsules and raw material found the pesticide chemical quintozene. The Report of Sample Analysis is attached for your information.

This article is adulterated within the meaning of 21 U.S.C. 342(a)(2)(B) while held for sale after shipment in interstate commerce in that it bears and contains a pesticide chemical, namely, quintozene, which is unsafe within the meaning of 21 U.S.C. 346(a) since no tolerance or exemption from tolerance has been granted for the use of such pesticide chemical on ginseng.

FDA previously collected a sample of Solaray Korean Ginseng, lot #‘s 062207 and 071202, [redacted] These products were also adulterated within the meaning of 21 U.S.C. 342(a)(2)(B) in that they contained quintozene, an unsafe pesticide chemical. The Report of Sample Analysis is attached for your information.

As a manufacturer of food within the meaning of 21 U.S.C. 321(ff), you are responsible for assuring that the products you distribute are not adulterated and are otherwise in compliance with the law. Failure to do so may result in regulatory action, without further notice, such as seizure and/or injunction.

You should notify this office in writing, within 15 working days of receipt of this letter, of the steps you have taken to correct these violations and preclude their recurrence. Your response should include details regarding your intent with respect to these specific lots of Solaray Brand Korean Ginseng Capsules, including product already distributed; the specific lot of raw material ginseng; and any other lots of capsules manufactured from this lot of raw material ginseng. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed: Please include copies of any available documentation demonstrating that corrections have been made.

Your response should be sent to H. Tom Warwick, Compliance Officer, Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. He may be reached at (303) 236-3054 if you have any questions about this matter.

Sincerely,

/s/
B. Belinda Collins
District Director

Enclosed: As stated