| Public Health Service Food and Drug Administration |
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700 |
Department of Health and Human ServicesWARNING LETTER
VIA UNITED PARCEL SERVICE
Our Reference: FEI 3005339127
May 4, 2011
Kevin T. Trieu, Owner
Southeast Asian Food Product
1166 Shafter Avenue #B
San Francisco, California 94124
Dear Mr. Trieu:
We inspected your seafood processing facility, located at 1166 Shafter Avenue #B, San Francisco, California, on December 27, 28, 31, 2010 and January 4, 7, 14, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or 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 refrigerated, vacuum packaged, ready-to-eat fish cakes and refrigerated ready-to-eat fish balls are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge receipt of your revised HACCP plan, dated 1/23/11, for your fish cake and blank monitoring records, in response to the FDA 483 List of Observation. Your response to the current inspection does not adequately address the deviations observed. The deviations listed in the warning letter related to your fish cake products are based on our evaluation of your revised HACCP plan. We recommend that you consider hiring a qualified consultant who has successfully completed training in the application of seafood HACCP principles to assist you in preparing and implementing a written HACCP plan.
Your serious deviations, which were noted upon further review of your HACCP plans, are as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as “a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.”
a. However, your firm’s revised HACCP plan for “Fish Cakes”, dated 1/23/11, fails to list the critical control point for the product formulation during the mixing and blending of the ingredients, to control Clostridium botulinumtoxin formation in the finished product fish cake, necessary to consistently achieve a water activity of less than 0.97. If you select not to use product formulation as a method for controlling Clostridium botulinum growth and toxin formation, your firm will need to implement additional assurances for product safety, such as the use of time and temperature integrators on each product package. We note that this revised plan includes a storage critical temperature limit of (b)(4), however, this alone is not adequate as a control method for products that are packaged in oxygen impermeable films since there is no assurance that the products will be continuously maintained at or below (b)(4) for the duration of the product’s shelf life.
b. However, your firm’s HACCP plan for “Fish Ball,” dated 9/29/08, fails to list the critical control point of Cooling After Cooking to control pathogen growth and toxin formation, for example, Staphylococcous aureus toxin formation.
2. You must have a HACCP plan that at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for “Fish Cake” lists a critical limit (b)(4) at the Cooling critical control point that is not adequate to control pathogen growth and toxin formation. Specifically, your HACCP plan does not list a combination of product internal temperature and the length of time between the end of the cooking step and packaging and labeling step. If the product is held at internal temperatures above 70°F during processing, FDA recommends that exposure times be limited to two hours (three hours if Staphylococcus aureus is the only pathogen of concern). On January 7, 2011, the FDA investigator observed that after frying, the fish cakes were placed on (b)(4). These fish cakes were then cooled down for (b)(4) on them directly with a (b)(4). To the FDA, the use of the (b)(4) and the (b)(4) is considered significant handling of the cooked fish cakes. The cumulative time/temperature exposure to unrefrigerated conditions should be calculated from the time the product is first handled after cooking.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 2 CFR 123.6(c)(4).
a. However, your firm’s HACCP plan for “Fish Cake” lists a monitoring procedure of (b)(4) at a frequency of (b)(4) at the Cold Storage critical control point that is not adequate to control pathogen growth and Clostridium botulinum toxin formation. Intermittent temperature checks do not provide any information related to temperatures between the checks, which in your case could include up to (b)(4) hours between checks. FDA recommends using a digital time/temperature data logger or a recorder thermometer with continuous monitoring of the cooler temperature by the instrument itself, with visual check of the monitoring instrument at least once per day.
b. However, your firm’s HACCP plan for “Fish Ball” lists a monitoring procedure of (b)(4) at a frequency of (b)(4) at the Cold Storage critical control point that is not adequate to control pathogen growth and toxin. As discussed above, intermittent temperature checks do not provide any information related to the temperatures between those checks.
4. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, between September 18, 2010 and December 27, 2010, your firm manufactured fish cakes and fish balls but you did not monitor and keep records of the cooler temperature. On January 14, 2011, during the closeout meeting with FDA, your production assistant confirmed to the FDA investigator your firm failed to implement the monitoring procedures for the finished products cold storage (b)(4) between September 18 and December 27, 2010. In addition, your firm did not monitor the temperature of the cold storage (b)(4) at the frequencies (b)(4) specified in your HACCP plan for fish balls.
5. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(d). However, your firm did not take an appropriate corrective action to control pathogen growth and Clostridium botulinum toxin formation when your cooler temperature (b)(4) deviated from your critical limit at the “Cold Storage” critical control point. Specifically, your temperature recording chart for the week dated July 14, 2010, shows that the cooler temperature was at 45°F for three days from approximately (b)(4) Your firm exceeded your critical limit at the Cold Storage critical control point but there were no records to show that a corrective action was taken.
6. Because you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).
a. However your corrective action plan for Fish Cake at the Cold Storage critical control point to control pathogen growth and Clostridium botulinum toxin formation is not appropriate. Your HACCP plan lists (b)(4) Your corrective action does not ensure that adulterated product does not enter commerce and that the cause of the deviation is corrected. Similarly, your corrective action plan listed in your “Fish Ball” HACCP plan at the Cold Storage critical control point to control pathogen growth is also not appropriate.
b. In addition, your corrective actions listed in your HACCP plans for “Fish Cakes” and “Fish Ball”at the “Packaging and Labeling” critical control points are not adequate (i.e., to control the hazard of undeclared allergens). (b)(4) does not correct the cause of the deviation. Your firm should also ensure that no products were distributed with the incorrect labels, prior to the review step.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Additionally, your firm’s HACCP plan for “Fish Ball” lists a critical limit (b)(4) at the Cold Storage critical control point that is not adequate to control pathogen growth and toxin formation. FDA recommends that the temperature of the finished product cooler be held at 40°F or below. In addition, we note that your HACCP plan (b)(4) for information related to the “Method of Storage and Distribution.” This information should also be corrected.
You should 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 these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Ms. Darlene Almogela, Director, Compliance Branch, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Ms. Figueroa, Compliance Officer, at (510) 337-6795.
Sincerely,
/S/
Barbara J. Cassens
District Director
San Francisco District
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