Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
October 8, 2014
Ernest Y. Doizaki, CEO
Prospect Enterprises, Inc.
621 Kohler Street
Los Angeles, CA, 90021
Dear Mr. Doizaki:
We inspected your seafood processing and importer establishment, located at 535 Harbor Lane, San Diego, CA, from August 18-27, 2014. 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).
Accordingly, your fishery products including canned crab meat, salmon, yellow tail, oysters, and clams, 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.
On August 17, 2014 we received a response letter from Mr. Shivas K. Shima, General Manager of the facility location, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm at the conclusion of the inspection. We address the response below, in relation to each of the noted violations. Your significant violations were as follows:
1. 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 “Refrigerated Vacuum Packed Raw or Ready to Eat Seafood Products (Non-Scombroid)” lists a monitoring procedure at the Receiving critical control point, CCP#1, that is not adequate to controlClostridium botulinum growth and toxin formation.
Specifically, your monitoring procedure for the receiving person to take the “(b)(4)” for “(b)(4)” does not ensure the canned crab meat does not exceed the critical limit of ≤ 38°F during transportation lasting more than 4 hours. For example, on 08/17/14 you received cans of refrigerated (b)(4) Dungeness crabmeat (b)(4) that was shipped from Astoria, Oregon on 08/15/14.
We have reviewed your firm’s response and conclude that it is not adequate. Your response included a revised HACCP plan. The monitoring procedure listed in the revised HACCP plan “(b)(4)” is not adequate to controlClostridium botulinum growth and toxin formation. Time Temperature Indicators (TTIs) are designed to provide the consumer or end user (the consumer who opens the sealed container) a way of determining if the packaged product has been exposed to conditions that could have resulted in the formation of Clostridium botulinum toxin. TTIs cannot replace the time and temperatures controls that are necessary to prevent pathogen growth and toxin formation. For additional guidance on controls for secondary processors see the FDA Fish and Fisheries Products Hazards and Controls Guide (The Hazards Guide), 4th Edition, Chapter 13, Control Strategy 2E.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure and frequency of monitoring the “(b)(4)” using a “(b)(4)” to provide “(b)(4)” at the refrigeration critical control point to control Clostridium botulinum in refrigerated canned crab meat.
Specifically, on 8/18/14 pasteurized crabmeat in metal and plastic cans (reduced oxygen packaging) was stored in cooler # 4. Cooler # 4 does not have a chart recorder or data logger. In addition, the temperature was measured at 47oF with a calibrated FDA thermometer.
We have reviewed your firm’s response and conclude that it is not adequate. You state that an additional temperature recorder has been installed where the crab was stored. You also provided a copy of records covering the purchase of a chart recorder and photos of the new recorder mounted on the cooler wall. However, you have not provided records that you have verified it is operational and accurate, and you have not provided any monitoring records demonstrating it is in use.
3. 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 “Fresh Fish Filleting and Seafood Products (Non-Scombroid)” does not list the hazard of undeclared allergens.
We have reviewed your firm’s response and conclude that it is not adequate. Your response includes a revised copy of the HACCP plan that identifies the hazard and includes a CCP at the labeling step. However, the monitoring procedure listed in the plan “(b)(4)” does not ensure that labels from each batch, lot, or different product are reviewed to ensure proper allergen declaration. In addition, the corrective actions listed in the plan “(b)(4)” does not address the cause of the deviation. For additional guidance on finished product allergen labeling controls see the Hazards Guide, Chapter 19, Control Strategy 8.
4. You do not have records to document the performance and results of the affirmative steps taken to demonstrate that fish and fishery products imported into the United States were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(c).
For example, your firm imports aquacultured salmon from Chile (b)(4); mahi-mahi, swordfish, and sea bass from Costa Rica (b)(4), tuna from Sri Lanka (b)(4), and mahi-mahi, and sea bass from Ecuador (b)(4). You lack documentation of the affirmative steps taken for the foreign suppliers.
We have reviewed your firm’s response and conclude that it is not adequate. Your response states “We have attached copies of the required documentation from each of the foreign processing plants the facility currently imports from (b)(4): signed by their senior plant officials.” Your response includes the documentation for the three firms you have listed. However, you have not provided documentation for all the foreign suppliers you currently import fishery products from. Our records indicate that your firm also imports from the following additional foreign suppliers:
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination", seize your product(s) and/or enjoin your firm from further violating the Act.
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 importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention:
Tamara Umscheid, Acting Director
Los Angeles District
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
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.
Alonza E. Cruse, Director
Los Angeles District
Shevis K. Shima, General Manager
Prospect Enterprises, Inc.
DBA Chesapeake Fish Company
535 Harbor Lane
San Diego, CA, 92101-5809
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413