Inspections, Compliance, Enforcement, and Criminal Investigations
Sunja's Oriental Food Inc. 30-Dec-03
Department of Health and Human Services
Public Health Service
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
December 30, 2003
Sunjas Oriental Food Inc.
40 Foundry Street
Waterbury, VT 05676
Dear Ms. Hayden:
We inspected your seafood processing facility, located at 40 Foundry Street, Waterbury, VT on November 6, 13 and 17, 2003 to determine your compliance with FDAs Seafood Hazard Analysis Critical Control Point (HACCP) Regulations 21 CFR Part 123, Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, and the Good Manufacturing Practices (GMP) requirements for foods, 21 CFR Part 110.
The Seafood HACCP Regulations were issued pursuant to Section 402(a)(4) of
the Federal Food, Drug and Cosmetic Act (the Act). Seafood that is processed
in violation of the HACCP regulations is adulterated, according to the Act,
because it has been prepared, packed, or held under insanitary conditions whereby
it may have become contaminated with filth, or may have been rendered injurious
to health. You can find this Act and the Seafood HACCP Regulations through links
in FDAs home page at
The seafood processing regulations, which became effective on December 18,
1997, require that you implement a preventive system of food safety controls
known as HACCP. HACCP involves:
(1) identifying food safety hazards that, in the absence of controls, are reasonably likely to occur in your products; and
(2) having controls at critical control points in the processing operation to eliminate or minimize the likelihood that the identified hazards will occur.
Prudent processors already take these kinds of measures. HACCP provides a systematic way of taking those measures that demonstrates to FDA, to your customers, and to consumers, that you are routinely practicing food safety by design. Seafood processors that have been fully operating HACCP systems advise us that they benefit from it in several ways, including having a more safety oriented workforce, having less product waste, and having fewer problems generally.
During our inspection, the investigator provided you with the form FDA 483,
which presents her evaluation of your firms performance regarding various
aspects of the HACCP and GMP requirements. Upon further review, we found that
you have a serious deviation from the HACCP Regulations. 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 otherwise operate in accordance with the
requirements of this part, renders the fishery products processed there 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 ready-to-eat sushi rolls
are adulterated, in that the product has been prepared, packed, or held under
insanitary conditions whereby it may have been rendered injurious to health.
The serious deviation observed was as follows:
You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11 (c). However, your firm does not maintain sanitation monitoring records for the eight areas of sanitation required for the processing of sushi rolls, a ready-to-eat product.
We may take further action if you do not promptly correct this above violation. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Please respond in writing within fifteen (15) working days from your receipt
of this letter. Your response should outline the specific things you are doing
to correct this deviation. You should include in your response any documentation,
such as your HACCP plan, 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 deficiencies.
This letter does not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Additionally, we understand that you have updated your HACCP plan to include thawing as a CCP. Please provide us with a copy of your revised plan. Also, you should note that the food safety hazard of pathogens, which is associated with your sushi rolls, may be controlled by ensuring that the product is not exposed to times and temperatures which may be conducive to the growth of pathogenic microorganisms. You may control pathogen growth by monitoring your storage temperatures using any continuous logging method, or by using a high temperature alarm. You may wish to refer to Chapter 12 of the Fish and Fisheries Products Hazards and Controls Guidance for examples of some of the FDA recommended controls and critical limits.
You may direct your reply to Karen N. Archdeacon, Compliance Officer, at the
address noted above. If you have any questions concerning this matter, please
contact Ms. Archdeacon at (781) 596-7707.
Gail T. Costello
New England District Office