Inspections, Compliance, Enforcement, and Criminal Investigations
Rel's Foods Inc. 04-Feb-04
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL, EXPRESS
Our Reference: 2915995
February 4, 2004
Soren P. Sorensen, President
Rels Foods Inc.
468 1 Telegraph Avenue
Oakland, California 94609
Dear Mr. Sorensen:
On November 4, 10, and 12, 2003, we inspected your processing facility located
at 975 W. Grand Avenue, Oakland, California. We found that you have serious
deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP)
Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In
accordance with 21 CFR 123.6(g), failure of a processor to have and implement
a HACCP plan that complies with this section or to otherwise operate in accordance
with the requirements of 21 CFR Part 123, renders the fishery products adulterated
within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act (the Act), 21 U.S.C. 342(a)(4). Accordingly your tuna salad sandwiches are
adulterated, 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. You may find the Act and the
Seafood HACCP Regulations through links in FDAs home page at www.fda.gov.
See the attached handout explaining how you can obtain a copy of the Fish &
Fisheries Products Hazards and Controls Guidance, 3rd edition, June 2001.
The deviations observed were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and you must have a written HACCP plan for tuna salad sandwiches to control the food safety hazard of pathogen growth, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for tuna salad sandwiches to control the food safety hazard of pathogen growth and toxin formation as a result of time/temperature abuse. We acknowledge receipt of your letter of November 10, 2003 stating that your firm will immediately begin preparation of an appropriate HACCP program.
2. You must maintain sanitation control records that, at a minimum, document
the monitoring and corrections prescribed by 21 CFR 123.11(b), to comply with
21 CFR 123.11(c). However, your firm does not maintain the following sanitation
monitoring records, which are required for the processing of tuna sandwiches
to control the food safety hazard of pathogen growth and toxin formation as
a result of time/temperature abuse:
Safety of the water
Condition and cleanliness of food-contact surfaces
Prevention of cross-contamination
Maintenance of hand washing, hand sanitizing, and toilet facilities
Protection of food, food packaging material, and food contact surfaces from adulteration with contaminants
Proper labeling, storage, and use of toxic compounds
Control of employee health conditions that could result in microbiological contamination, and
Exclusion of pests from the facility.
You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b).
3. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm failed to monitor prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, as evidenced by FDA observation of a wet, balled-up paper towel on your firms [redacted] which was fabricated to act as a tension pulley support for your conveyor belt.
At the conclusion of the inspection, the observed deviations were listed on Form FDA 483 and discussed with you. A copy of this form is enclosed for your ready reference This list is not meant to be an all-inclusive list of violations. You are responsible for ensuring that your processing facility operates in compliance with the Act, the Seafood HACCP Regulations, and the Current Good Manufacturing Practice Regulations (21 CFR 110).
We may take further action if you do not promptly correct these violations.
For instance, we may take further action to seize your products and/or enjoin
your firm from operating. Please respond in writing within fifteen (15) working
days of receipt of this letter. Your response should outline the specific things
you are doing to correct these deviations. You should include in your response
documentation or other useful information that would assist us in evaluating
your corrections. If you cannot complete all corrections before you respond,
we expect that you will explain the reason for your delay, and state when you
will correct any remaining deviations.
Please send your reply to: Ms. Harumi Kishida, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Kishida at (510) 337-6824.
Charles M. Breen
Acting District Director
San Francisco District