Inspections, Compliance, Enforcement, and Criminal Investigations
Swedish Fish Company 22-Oct-02Department of Health and Human Services Public Health Service
Food and Drug Administration
Baltimore District Office
6000 Metro Drive Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5703
Refer to: FEI 3001465117
October 22, 2002
CERTIFIED MAIL - RETURN RECEIPT REQUESTED
Mr. Leif Klasson
Swedish Fish Company
346 1 Washington Boulevard
Arlington, VA 22201
Dear Mr. Klasson,
On September 18, 2002 the Food and Drug Administration
(FDA) conducted an inspection of your facility located at 3461 Washington
Boulevard, Arlington, VA. The inspection was conducted to determine your
firm?s compliance with FDA?s Fish and Fishery Products regulations at
Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and the Good
Manufacturing Practices regulations for food at Title 21, Code of Federal
Regulations, Part 110 (21 CFR 110).
During our inspection, the FDA investigators observed
serious deviations from the regulations. The FDA investigators provided
you with a copy of the investigators? observations (FDA Form 483) and
the Import Seafood HACCP Report (form FDA 3502), which present the
investigators? evaluation of the firm?s performance regarding various
aspects of the HACCP requirements. The observations of concern to us are
1. Your firm does not have written HACCP plans to control
any food safety hazards that are identified as reasonably likely to occur,
as required by 21 CFR 123.6(b). Specifically, your firm does not have
written HACCP plans for all seafood products including, but not limited to
swordfish, salmon, tuna, halibut, grouper, shellfish products, and
2. Failure to maintain sanitation control records that,
at a minimum, document the monitoring and corrections of problems
involving: (1) safety of water that comes into contact with food or food
contact surfaces; (2) safety of water used to manufacture ice; (3)
prevention of cross-contamination; (4) maintenance of hand washing, hand
sanitizing, and toilet facilities; (5) protection of food, food packaging
material, and food contact surfaces from adulteration with contaminants;
(6) proper labeling, storage, and use of toxic compounds; (7) control of
employee health conditions that could result in microbiological
contamination; (8) and exclusion of pests from the facility (21 CFR 123.11
3. Fish or fishery products were obtained from a country
(Norway) that lacks an active
4. Failure to maintain equipment, containers, and
utensils used to convey and store food in a manner that protects against
contamination (21 CFR 110.80(b)(7)). For example:
Knives and other utensils used in the processing of seafood products were observed being stored in a bucket of dirty water that contained no detectable level of sanitizer. Employees were observed using utensils from this bucket to process fish without first washing and sanitizing them.
Accumulated old fish product was observed in etched portions of the poly cutting boards used to cut fish in the processing area.
No sanitizer is currently being used to clean equipment and food contact surfaces.
Accumulated flaking rust was observed on the interior ceiling of the ice machine in the back room, used to store ice for packing fish.
Accumulated flaking rust and dust were observed on the fan guards of the cooling unit located above the equipment sink and above/beside the processing tables in the processing area.
5. Failure to take effective measures to protect finished
food from contamination by raw materials in that, raw salmon was observed
being stored directly on top of cooked crab meat in the walk-in cooler,
directly adjacent to the processing area (21 CFR 110.80(b)(6)).
The above identified deviations are not intended to be an
all inclusive list of deficiencies at your facility. We note that FDA
documented similar deviations during your last inspection on May 21, 2001.
It is your responsibility to ensure that all seafood products processed
and distributed by your firm are in compliance with the Act and all
requirements of the federal regulations.
You should take prompt measures to correct these
deviations. Failure to promptly correct the deviations noted may result in
regulatory action without further notice. Such action includes seizure
and/ or injunction. In addition, FDA may detain your imported seafood
products without examination. Under such conditions, FDA will not issue
any Certificates for Export or European Union Health Certificates for any
of the affected fish and fishery products processed at your facility.
Please notify this office in writing within fifteen (15)
working days of receipt of this letter of the specific steps you have
taken to correct these violations, including an explanation of each step
taken to prevent their reoccurrence. Your response should include copies
of any available documentation demonstrating that corrections have been
made. If corrections cannot be made within 15 working days, state the
Your reply should be directed to the Food and Drug
Administration, Attention: Edward M. Creech, Jr., Compliance Officer, 7737
Hampton Blvd., Warehouse 4C, Room 206, Norfolk, VA 23505.
If you have questions regarding this letter or the
implementation of the HACCP regulation, you may contact Mr. Creech at
(757) 44l-3787 extension 11.
Director, Baltimore District