Inspections, Compliance, Enforcement, and Criminal Investigations
Roy and Malensky 07-Oct-05
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 96021-4421
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
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 <a href=">htttp:/www.fda.gov.
The deviations were as follows:
1. You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). However, your firm's HACCP plan for strawberry puree (4+1) does not list the food safety hazards of pathogens.
2. You must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm does not maintain sanitation control records for the following areas of sanitation:
Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
Maintenance of hand washing, hand sanitizing and toilet facilities;
Protection of food, food packaging materials, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants. Our investigators noted that clean plastic baskets for packaging fresh berries were stored in open cases in the warehouse where a bird was observed. Also, plastic cartons were stored outside in exposed cases and live insects were seen on several cartons;
Proper labeling, storage, and use of toxic compounds;
Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces.
You should take prompt action to correct these violations and prevent their recurrence. Failure to make prompt corrections could result in regulatory action without further notice. For instance, FDA may seize your violative products and/or enjoin your firm from operating.
It is essential that you respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct the deviations noted above. You may wish to include in your response documentation such as new HACCP plans, sanitation control records, or other useful information that would assist us in evaluating your corrections. If the corrective actions cannot be completed within fifteen working days, state the reason for your delay and the time within which you will correct any remaining deviations.
The above violations are not meant to be an all-inclusive fist of deficiencies for these products or their labeling or any other product your firm manufactures or labels. It is your responsibility to ensure that ail of your products comply with the laws and regulations enforced by FDA.
Please send your response(s) to the U. S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021, Attention: Michael J. Donovan, Compliance Officer. If you have questions regarding any issue in this letter, please contact me at (425) 483-4906.
Charles M. Breen