- Van Oriental Food, Inc
4828 Reading Street
Dallas, TX 75247-6705
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
November 3, 2014
Kim C. Nguyen, President
Theresa T. Motter, Chief Financial Officer
Van Oriental Food, Inc.
4828 Reading St.
Dallas, TX 75247-6705
Dear Mses. Nguyen and Motter:
We inspected your seafood processing facility, located at 4828 Reading St., Dallas, TX on April 23 through May 16, 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 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 shrimp egg rolls 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.
Your significant violations were 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." However, your HACCP plan for egg rolls intended for food service use does not list the critical control point (CCP) of cooking for controlling the food safety hazard of pathogen growth and toxin formation. When products are heat treated in a manner that renders the product with the appearance of a fully cooked product, a critical control point is needed to ensure that the product is heat treated sufficiently to result in a minimum six log reduction of Listeria monocytogenes in all cooked units to control for the hazard of pathogen growth and toxin formation. Labeling the product with cooking instructions and trusting food service establishments to fully cook the product does not provide an equivalent food safety assurance and does not negate the need for a cooking critical control point for the heat treatment process.
We acknowledge receipt of a letter dated May 29, 2014, from your QA Manager in response to the FDA 483. The letter states that the product is sold solely to food service accounts that fully cook the egg rolls before consumption, and that cooking instructions are included on each case. However, FDA considers your egg rolls to be ready to eat, in that they appear to be fully cooked. As such, your HACCP plan for this product should have a CCP to control the hazard of pathogens at the cook step.
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 retail egg rolls lists critical limits that are not adequate to control the identified hazards, as follows:
Your retail HACCP plan’s cook CCP lists a critical limit of, “Min Internal Prod Temp (b)(4)°F.” This critical limit alone is not adequate because it does not ensure that each shrimp egg roll achieves an adequate heat process during frying, and achieves a minimum six log reduction of Listeria monocytogenes. FDA’s safety recommendations are based on scientific data and indicate that a minimum internal temperature of (b)(4)°F must be maintained for at least (b)(4) minutes to achieve a minimum six log reduction of Listeria monocytogenes. Your current critical control point does not include a critical limit for that necessary holding time. FDA recommends that your critical limits be modified to include all of the critical process parameters (e.g., oil temperature, fryer dwell time, initial product temperature, product weight, post-fryer conveyor dwell time, belt speed, etc.) which ensure that this time and temperature combination are achieved rather than this single critical limit.
You have the option of utilizing a critical limit that uses the end-point internal product temperature (EPIPT) sufficient to result in a minimum six log reduction of Listeria monocytogenes. However, your critical limit should be supported by a scientific study that demonstrates that the cooking parameters necessary to achieve the EPIPT will result in a minimum six log reduction of Listeria monocytogenes in the slowest heating unit or portion of product under the worst set of heating conditions.
We acknowledge that during the inspection your firm provided our investigator with a copy of your Lethality Study of Shrimp Egg Roll Heat Processing, dated March 24, 2008. This study states that its objective was to confirm that your heat processing of shrimp egg rolls achieves a six logarithm reduction in the numbers of Listeria monocytogenes. However, the study does not provide adequate support for your current critical limit of “Min Internal Prod Temp (b)(4)°F” as an end-point internal product temperature (EPIPT). The study does not provide sufficient information to identify the critical factors for your cooking process and the factors that have an effect on the rate of process heating. Specific issues with the study include:
· There were no data provided on a temperature distribution study.
· The study does not define the process parameters (including upper and lower limits) that were in place to generate the Egg Roll heating curves, e.g. oil temperature, fryer dwell time, initial product temperature, product weight, or post-fryer conveyor dwell time. Considering the lack of processing parameter definition, this study cannot be compared/applied to the manufacturing process.
· It appears that only (b)(4) replicates were run for internal temperatures for the Egg Roll heating curves. Without description of the process it is we are unable to determine whether this is a sufficient sample size to be representative of the process.
· The calculation for D- and z-values appears to have come from a prior study where the cocktail of Listeria monocytogenes was inoculated in product, assembled, and processed, and then survivors were enumerated. We would need to see the data from this study, e.g., the strain(s) used, initial inoculum levels, analysis time points, controls, and methods (time/temp measurement and for enumeration) in order to evaluate the adequacy.
· The z-value from the previous study is reported as (b)(4)°F. The z-value is approximately (b)(4)°C based on graphic estimation using the D-values reported on page 2. This is higher than reported in the literature (Doyle et al., 2000, “Heat Resistance of Listeria monocytogenes”). In that review, z values for multiple strains in seafood and vegetables were found to be about 4-8°C.
· The study does not list recommended critical limits to achieve the calculated lethality. When EPIPT is to be used for a critical limit, the time at which EPIPT is taken should be defined, because all lethality occurs post-fryer exit.
· The study states that the targeted minimum F-value is (b)(4) for a 6 log kill, and concludes that this was achieved as long as product reaches (b)(4)°F. However, the data provided indicate that when product reaches (b)(4)°F, an F-value of (b)(4) was not consistently met. For example, in Table 1, series 1 reaches (b)(4)°F at (b)(4) minutes, and F-value is listed as (b)(4) (lower than target of (b)(4)). In Table 2, the (b)(4)°F model never reaches (b)(4)°F, and only achieves the target lethality at (b)(4) minutes, when it reaches (b)(4) F-value.
Consequently, we recommend that your firm (1) conduct a temperature distribution study within the heating system to identify any cold spots; (2) conduct a heat penetration study that accounts for the slowest heating product under the worst case heating conditions covered by the scientific study; and identify other critical factors (e.g., fryer cook temperature, belt speed, initial temperature of product, etc.) of processing and/or packaging that affect the rate of product heating when scientifically establishing a cooking process (i.e., process validation). The EPIPT should be used as a monitoring technique only under those conditions that were evaluated by the scientific study. Those conditions may need to be identified as critical limits and monitored as part of the HACCP plan.
Additionally, your cooking process includes monitoring the internal temperature of egg rolls as they exit the fryer on an (b)(4) basis. For continuous cooking the EPIPT needs to be monitored at least every 30 minutes and whenever any changes in product-heating critical factors occur. If EPIPT is not used, then the cooking critical process parameters must be monitored continuously.
Your firm’s response letter states that you have added time duration to the HACCP plan (i.e., as a critical limit) of (b)(4) minutes for the (b)(4). However, you did not state whether there are other additional critical factors, and have not provided a copy of the revised HACCP plan for our review, or the scientific data to support the revised critical limit, so we are not able to evaluate the corrective action.
In addition, your firm’s response letter states that you have updated your HACCP plan to remove sulfites from your labeling requirement, and you have sourced new ingredients that do not use sulfites. Since you have not provided a copy of the revised HACCP plan for our review, we are unable to evaluate this corrective action. However, please be advised that when firms elect to not declare sulfites on finished product labels because they are intending to use shrimp in their products that have not been treated with sulfiting agents, the HACCP plans for those firms should include a critical control point to monitor to ensure that you are purchasing untreated shrimp and/or that the finished product contains less than 10 ppm sulfites.
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.
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 and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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.
Please send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Seri Essary at (214) 253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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