Inspections, Compliance, Enforcement, and Criminal Investigations
A. C.' S Chinese Restaurant 4/17/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700
VIA UNITED PARCEL SERVICE
Our Reference: CMS 395567
April 17, 2013
Christopher L.B. Cho, Owner
A.C. Chinese Restaurant
73-5569 Kauhola Street, Bay 1
Kailua Kona, Hawaii 96745
Dear Mr. Cho:
We inspected your seafood processing facility, A.C. Chinese Restaurant, located at 73-5569 Kauhola Street, Bay 1, Kailua Kona, Hawaii on February 14, 16, 18, and 21, 2013. 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 (21 CFR 123). 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 shelf-stable, ready-to-eat dried marlin fish jerky is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
At the close of our inspection, the investigator provided Ms. Leonora T.K. Cho, Co-owner, with the form FDA 483, Inspectional Observations, which presents his evaluation of your firm’s performance regarding various aspects of the HACCP requirements. We attached a copy of the FDA 483 for your reference.
We acknowledge receipt of Ms. Leonora Cho’s March 1, 2013 letter in response to the FDA 483 inspectional observations. Ms. Cho’s response is not adequate in that no HACCP documents were included to support the corrections. The deviations listed in this letter are based on the inspection and our review of your response letter.
Your significant violations are 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 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 “AC’S/ASIA TRANS FISH JERKY” does not list the food safety hazards of histamine formation and pathogen growth and toxin formation including Clostridium botulinum toxin and Staphylococcus aureus toxin as a result of time/temperature abuse and inadequate drying, and the food safety hazard of allergens.
2. 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 “AC’S/ASIA TRANS FISH JERKY” does not list the critical control point of Thawing of vacuum packaged raw fish to control histamine formation and pathogen growth and toxin formation including Clostridium botulinum toxin that is reasonably likely to occur if the time and temperature are not adequately controlled during the thawing process. In addition, your HACCP plan does not list the critical control points of Cooler Storage/Marinating for controlling the food safety hazard of histamine formation and Finished Product Labeling for controlling the food safety hazard of allergens.
To establish the appropriate critical limits, monitoring procedures, corrective actions, verification, and record-keeping system for each critical control point, please refer to the Chapters 7, 13, and 19 of the 4th Edition of the HACCP Guide.
3. 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 “AC’S/ASIA TRANS FISH JERKY” lists critical limits (b)(4) at the Drying (Dehydrator) critical control point that are not adequate to control histamine formation and pathogen growth and toxin formation. FDA recommends that you also include the initial temperature of the fish slices as a critical limit and list a target water activity in the finished product (i.e., 0.85 or below).
To establish the appropriate monitoring procedures, corrective actions, verification, and record-keeping system in order to meet your critical limits, please refer to the Chapters 7 and 14 of the 4th Edition of the HACCP Guide.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “AC’S/ASIA TRANS FISH JERKY” lists a monitoring procedure of (b)(4) at the Drying (Dehydrator) critical control point that is not adequate to control histamine formation and pathogen growth and toxin formation including Clostridium botulinum toxin and Staphylococcus aureus toxin to achieve an adequate water activity for your dried marlin jerky. FDA recommends monitoring the drying time and oven temperature with a digital time and data logger, continuously, with a visual check of the recorded data of each batch. We noted that your HACCP record (b)(4) indicated (b)(4). Your records should indicate the start time and end time of the drying periods for each batch from the (b)(4) dehydrators.
5. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the Drying (Dehydrator) critical control point to control histamine formation and pathogen growth and toxin formation listed in your HACCP plan for “AC’S/ASIA TRANS FISH JERKY.” Specifically, the monitoring records associated with the Drying (Dehydrator) critical control point, which you provided to our investigator during the inspection, did not include records documenting the (b)(4) as specified by your critical limit.
6. Because you choose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan for “AC’S/ASIA TRANS FISH JERKY” to control pathogen growth and toxin formation at the “Drying (Dehydrator)” critical control point listed as (b)(4) is not appropriate. Your corrective action does not ensure that adulterated product will not reach the consumer.
7. 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, based on the investigator’s discussion with Ms. Cho, your firm does not maintain sanitation monitoring records for:
(a) Safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;
(b) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
(c) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;
(d) Maintenance of hand washing, hand sanitizing, and toilet facilities;
(e) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
(f) Proper labeling, storage, and use of toxic compounds;
(g) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
(h) Exclusion of pests from the food plant.
These records are required for the processing of shelf-stable, ready-to-eat, dried marlin jerky.
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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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 Federal Food, Drug, and Cosmetic Act and all applicable regulations
You should 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 violations. You should include in your response, documentation such as copies of the revised HACCP plan, HACCP monitoring records to demonstrate that you have implemented the revised plan, any verification records, and 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.
Please send your reply to the U. S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. Please reference the CMS number 395567 in your response.
If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
Elizabeth A. Kage
Acting District Director
San Francisco District