| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 3, 2010
W/L 10-11
Mr. Anderson Vuong, President
Meiko Food Company Inc.
2526 Chico Ave.
South El Monte, CA 91733
Dear Mr. Vuong:
We inspected your seafood processing facility, located at 2526 Chico Ave., South El Monte, CA 91733 on August 10-19, 2010. 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 (cGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HAACP 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 fish paste and ready-to-eat pasteurized fish ball products 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 HAACP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge the receipt of your written response letter dated August 31, 2010. The agency has reviewed your response and although some of the items that were discussed during the close out of the inspection appear to have been corrected (replacement of cutting boards and removal of strip curtains), we continue to have the following concerns because you have not provided any detailed evidence or documentation of your stated corrective actions.
Your significant violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have a HACCP plan for Raw Fish Paste to control the food safety hazards of Clostridium botulinum, metal and allergens.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11 (b). However, your firm did not monitor the exclusion of pests; condition and cleanliness of food contact surfaces; proper labeling, storage and use of toxic chemicals; and safety of water with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. Exclusion of Pests: flies were observed in contact with fish paste and an apparent slug was observed on your Hobart mixer.
b. Condition and Cleanliness of Food Contact Surfaces: processing machines with fish parts inside due to lack of proper cleaning (failure to disassemble and clean). Black spots and yellow stains on tubs.
c. Proper Labeling, Storage and Use of Toxic Chemicals: use of a lawn and garden sprayer to hold bleach used on processing equipment.
d. Safety of Water: lack of backflow device on hose used to rinse processing equipment.
3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice and exclusion of pests required for the processing of fish paste and ready-to-eat pasteurized fish balls.
4. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11 (b), to comply with 21 CFR 123.11(c). However your firm did not maintain adequate sanitation monitoring records for condition and cleanliness of food contact surfaces including utensils required for the processing of fish paste. The records are inadequate because the requirement of entering information at the time it is observed, per 21 CFR 123.9(a) (4), is not present.
Considering the observations in item 2 above found at your firm, your sanitation records on 08/10/10 showed a "P" for pass for the sections: "Food Contact Surfaces and Utensil Cleaned and Sanitized", "Toxic Compounds Identified and Stored Properly", "Employee Practices Do Not Result in Cross Contamination". In addition, your sanitation log for August 2010 showed that on 08/12/10, you had marked "P" for pass for the section "Employee Health Conditions are Acceptable" when it was observed that your employees had not yet arrived at your facility.
5. 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 ready-to-eat pasteurized fish balls does not list a critical limit at the "Seal Integrity" Critical Control Point to control pathogen growth and toxin formation. FDA recommends that in addition to visually monitoring seal integrity, processors should also conduct detailed examinations of sample pouches such as burst testing or peel testing. Chapter 18 of the Fish and Fisheries Products Hazards & Controls Guidance: Third Edition can provide guidance in determining the appropriate controls for your process.
6. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c) (4). However, your firm's HACCP plan for Pasteurized Ready to Eat Fish Balls does not list the monitoring frequency at the "Monitoring Cooler Containing Packaged Products" critical control point to control Clostridium botulinum.
FDA recommends that, in order to adequately ensure that safe temperatures are consistently maintained during storage, ambient temperature monitoring should be conducted on a continuous basis with a visual check of the equipment's function once or more per day and a review of the temperature chart to assure that critical limits have not been exceeded. For more information on monitoring procedures for control of Clostridium botulinum, please refer to Chapter 13 of the Fish and Fisheries Products and Hazards and controls Guidance 3rd Edition (the Hazard Guide).
7. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123,7(a). However, your film did not take a corrective action to control Clostridium botulinum when your process for fish paste deviated from your critical limit at the "Cooler for Package Product" critical control point. Your monitoring log for August 2010 showed that you had exceeded your critical limit of 35°F -40°F from 08/03/10 to 08/12/10 and took no corrective action.
8. You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of taking fish balls out of the pasteurizer after 20 minutes to control Clostridium botulinum at the "HACCP Plan for Pasteurization in Hot Water" critical control point. You were observed taking fish balls out of the pasteurizer after only 14 minutes whereas your critical limit is 20 minutes. You did not fill out a corrective action/preventive action form.
9. 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 ready-to-eat pasteurized fish balls lists a critical limit, "184°F for 20 minutes", at the Batch Pasteurization critical control point that is not adequate to control Clostridium botulinum. Chapter 17 of the Fish and Fisheries Products Hazards & Control Guidance: Third Edition can provide guidance for determining appropriate critical limits.
We note that you have listed an internal temperature critical limit at your Batch Pasteurization CCP, but have not listed monitoring procedures to assure that the critical limit is met. Internal temperatures should normally be considered a verification procedure to assure that your cook times and temperatures are sufficient to control the target pathogen and are not recommended as critical limits.
(Note: The minimum or maximum values for the critical factors should be established with a scientific study. These critical factors may include length of pasteurization cycle, temperature of the water, initial temperature of the product, container size, and product formulation which should be included in your plan if necessary.)
10. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1), A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for ready-to-eat pasteurized fish balls does not list the food safety hazards of allergens and metals.
11. 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." However, your firm's HACCP plan for ready-to-eat pasteurized fish balls does not list the critical control point of "ice water bath" for controlling the food safety hazard of pathogen growth. Ice water bath is utilized for cooling product; however, it was not identified as a critical control point for residual chlorine in the Pasteurization HACCP plan.
12. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your film did not verify the adequacy of the critical limit of "time and temperature" for the ready-to-eat pasteurized fish balls at the "Batch Pasteurization" critical control point to control pathogen growth.
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 film from operating. 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 Food and Drug Administration, Attention:
Blake Bevill
Director, Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Dr. Raymond W. Brullo, Compliance Officer at (949) 608-2918.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
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