Inspections, Compliance, Enforcement, and Criminal Investigations
Pulmuone Foods USA, Inc. 2/6/14
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
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUIRED
February 6, 2014
Patrick Lemoine, President/CEO
Pulmuone Foods USA, Inc.
2315 Moore Avenue
Fullerton, CA 92833
Dear Mr. Lemoine:
We inspected your seafood processing facility located at 5755 Rossi Lane, Gilroy, CA 95020 between the following dates: September 19 and 30, 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 seafood products, including refrigerated lobster ravioli in reduced oxygen packaging and seafood lasagna bakes, containing shrimp, lobster and crab meat, in vacuum sealed packages 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 the receipt of your letter, dated October 17, 2013, in response to the form FDA 483, Inspectional Observations, issued to you on September 30, 2013. However, your response is not adequate in that revised HACCP plans were not presented. To determine the adequacy of your response, we will need to review your written HACCP plans. The deviations listed in this letter are based on the inspection and our review of your firm’s HACCP Plan for lobster ravioli entitled “CCP Summary Plan for Meat/ Poultry / Seafood Pasta” dated March 15, 2013 and your firm’s HACCP Plan for seafood lasagna entitled “CCP Summary Plan for Meat/ Poultry / Seafood Bakes” dated May 5, 2013 that were collected during the inspection.
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 plans for lobster ravioli and seafood lasagna do not list the food safety hazards of pathogens, such as Listeria monocytogenes, as a result of time and temperature abuse, and undeclared allergens.
FDA considers the lobster ravioli and lobster lasagna processed by your firm ready-to-eat products based on the processing times and temperatures during the steam “pasteurization” step. The products are likely to be considered fully cooked by the consumer based on their appearance. FDA recommends that your cook process be validated to achieve a 6 log reduction of Listeria monocytogenes.
Please refer to Chapter 12 (Pathogens) of the 4th Edition of the Hazards Guide for guidance in determining the appropriate controls for your process.
With regard to the hazard of undeclared allergens, FDA has identified shellfish as a major food allergen and consequently a food safety hazard that must be addressed in your HACCP plans. Additionally, other allergenic ingredients such as wheat, milk, and eggs, in your finished products need to be considered and addressed in your HACCP plans, when necessary. We suggest that processors conduct a visual examination of their labels prior to use by comparing the label with product to be labeled including the ingredients and ingredients’ labels to ensure that all allergenic ingredients are accurately declared. In addition, your firm must declare the common and usual name of the fish when labeling allergens. Please refer to Chapter 19 (Undeclared Major Food Allergens) of the 4th Edition the Hazards Guide for guidance in determining the appropriate controls for your process. The FDA Fish List can provide a reference list for what FDA considers the common and usual name for specific fish species.
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 plans for refrigerated lobster ravioli and seafood lasagna do not list the following critical control points:
a) Thawing for controlling the food safety hazard of Clostridium botulinum growth and toxin formation during the thawing process of frozen lobster meat in their vacuum-sealed packages.
FDA recommends that vacuum package frozen raw or unpasteurized fish or fishery products not be exposed to ambient temperatures above 38ºF (3.3ºC) during thawing. Your firm also has the option of opening the packaging prior to the thaw process and eliminating the hazard of Clostridium botulinum during that processing step or strictly limiting exposure times to temperatures above 38ºF (3.3ºC) .
b) Cold Storage for controlling the food safety hazard of Clostridium botulinum growth and toxin formation during finished product storage of lobster ravioli and seafood lasagna in their reduced oxygen packages.
Please refer to Chapter 13 (Clostridium botulinum Toxin Formation) of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) for information on recommended control strategies related to Clostridium botulinum for both refrigerated and frozen products.
3) Your plans fail to list a critical control point to control Clostridium botulinum growth and toxin formation in your refrigerated lobster ravioli and lasagna packaged in reduced oxygen packages. Your plans do not list controls to assure that your products achieve a sufficient water activity (>0.97), water phase salt (<5.0%), or pH (<5.0) to reduce the potential for Clostridium botulinum growth and toxin formation. Your firm can either provide these controls through product formulation or affix time/temperature integrators to each finished product package which will indicate to consumers when the products have been exposed to potentially unsafe times and temperatures.
Please refer to Chapter 13 (Clostridium botulinum Toxin Formation) of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) for information on recommended control strategies related to Clostridium botulinum for refrigerated unpasteurized, cooked products.
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. 379, 2/j-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.
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 copies of any revised HACCP plans, HACCP monitoring records to demonstrate that you have implemented the revised plans, 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.
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 attention:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference the CMS number 416366 in your response.
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Kathleen M. Lewis, J.D.
San Francisco District Director
cc: Miguel A. Saez, VP Technical Gilroy
Pulmuone Foods USA, Inc.
5755 Rossi Lane
Gilroy, CA 95020