| Public Health Service Food and Drug Administration |
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human Services
July 15, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-18
Larry B. George, President
George Packing Company, Inc.
P.O. Box 778
Newberg, Oregon 97132
WARNING LETTER
Dear Mr. George:
On March 1 - 24, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your hazelnut packing house and warehouse located at 15195 NE Ribbon Ridge Road, Newberg, Oregon, and collected nine finished product samples and a filth sample from various locations within your facility. The inspection revealed that your hazelnuts are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health, and within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(3)], in that they consist in whole or in part of a filthy, putrid, or decomposed substance, or are otherwise unfit for food. You can find links to the Act and FDA’s regulations through links on FDA’s website at www.fda.gov.
The food at your facility is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that it was prepared, packed, and held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. For example, our investigators broke down a pallet of Barcelona hazelnuts and observed a dead rodent among gnawed hazelnuts and numerous rodent pellets. In addition, at the time of the inspection, our investigator observed a gap under the door and between the door and the door frame on the rolling door on the west wall, as well as a gap under the rolling door on the north wall. These gaps were sufficient for rodents to gain access to the warehouse. Our investigator documented that you corrected these gaps prior to the close of the inspection. Nevertheless, our evidence demonstrates that rodents were already in the facility. Closing the gaps does not control the rodents that had already gained access.
Your hazelnuts are also adulterated within the meaning of section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)], because they consist in whole or in part of a filthy, putrid, or decomposed substance, or are otherwise unfit for food. For example, a sample comprised of 10 subsamples collected from bags of Ennis and Barcelona hazelnuts on pallets throughout the facility during our inspection was analyzed for filth. Every subsample yielded evidence of rodent activity and filth. The evidence included mouse pellets, gnaw marks on shells and bags, feathers, human hair, mouse hair and dog/cat hair.
We acknowledge your March 26, 2011, response to the FDA 483. Your letter states that your staff cleaned and sanitized your facility after our investigation. However, you did not provide specific documentation of the procedures used in order for us to undertake an informed evaluation of your corrective actions.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with the Act and FDA regulations. You should take prompt action to ensure that your hazelnuts are not manufactured under conditions which may cause them to be contaminated with filth or rendered injurious to health. Failure to promptly correct violations of the Act may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should include each step that has been taken to completely correct the current violations and to prevent the recurrence of similar violations, the timeframe within which each correction will be completed, and any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Patricia A. Pinkerton, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Patricia A. Pinkerton at
(425) 483-4926.
Sincerely,
/S/
Charles M. Breen
District Director
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