Inspections, Compliance, Enforcement, and Criminal Investigations
Roy and Malensky 07-Oct-05
| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 96021-4421 Telephone: 425-486-8788 FAX: 425-463-4996 |
Department of Health and Human Services
October 7, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-08
Roy J. Malensky, Owner
Roy and Barb Malensky
d.b.a. Oregon Berry Packing Company
6000 SW Minter Bridge Road
Hillsboro, OR 97123
WARNING LETTER
Dear Mr. Malensky:
The U.S. Food and Drug Administration (FDA) inspected your firm, located at 6000 SW Minter Bridge Road, Hillsboro, Oregon 97123, on June 27, 2005. We found that you have serious deviations from the Juice HACCP regulations (21 CFR Part 120). These deviations, some of which were previously brought to your attention, cause your strawberry puree to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations, including the Juice HACCP Regulation, through links on FDA's Internet homepage at
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