Inspections, Compliance, Enforcement, and Criminal Investigations
SSE Manufacturing, Inc 5/14/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
May 14, 2014
Douglas Olsem, President
Schwan’s Global Supply Chain, Inc.
115 West College Drive
Marshall, MN 56259
Dear Mr. Olsem:
We inspected your seafood processing facility, SSE Manufacturing, Inc., located at 612 Georgia Avenue, Deer Park, Texas, from November 13 to December 10, 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 shrimp egg roll and crab rangoon 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 HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge receipt of a letter dated December 27, 2013, sent in response to the FDA 483, with attached documents. However, review of these documents reveals that your firm has not made complete corrections to the observations made during the inspection, as noted below.
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 revised HACCP plan for shrimp egg rolls and crab rangoon does not list the food safety hazard of food intolerance substances, specifically the potential for undeclared sulfiting agents in the shrimp ingredient used in your shrimp egg rolls.
Sulfiting agents are food intolerance substances that are frequently used on raw shrimp to prevent black spot formation. People who are sensitive to sulfiting agents can experience symptoms that can range from mild severity to life-threatening reactions. Because of the potential for sulfiting agents in the shrimp ingredient, we recommend identifying undeclared sulfites as a hazard in your products that contain shrimp.
Additionally, during the inspection it was noted that the labels of incoming shrimp ingredient are checked for the declaration of sulfiting agents. Since your firm appears to be using a monitoring procedure associated with monitoring of labels at receipt as a control strategy, to ensure consistent and continued implementation of this strategy, we recommend that your HACCP plan include a critical control point at receiving and include appropriate corresponding monitoring procedures. We also recommend analyzing the shrimp on a quarterly basis for the presence of sulfiting agents, as ongoing verification.
Further, because your crab rangoon and shrimp egg rolls have differing hazards, we recommend that you have separate HACCP plans for these two products.
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 revised HACCP plan for shrimp egg rolls and crab rangoon lists a critical limit, “internal temperature of (b)(4) degrees for (b)(4) seconds” at the cook step critical control point that is not adequate because it does not ensure that each unit of shrimp egg rolls or crab rangoon achieves an adequate heat process during frying (i.e., achieves the listed “6D thermal lethality for Listeria monocytogenes”).
FDA recommends procedures for monitoring the control of bacterial pathogens through cooking or pasteurization as: 1) continuously monitoring all heat process critical factors, such as time and temperature measurements, or 2) measuring the internal temperature of a representative number of product units as they exit the heat process, along with other critical factors that have an effect on the rate of process heating to assure a six log reduction is achieved. This second method is referred to as “End-Point Internal Product Temperature,” or “EPIPT.”
While a processor may use the EPIPT method and monitor the internal temperature of a certain number of units of product on a periodic basis (rather than perform continuous time and temperature monitoring), the processor should first determine which of its process factors have an effect on the rate of process heating, and include these factors in its heating step as critical limits. These factors may include, but are not limited to, fryer temperature and heat distribution, fryer load, and belt speed. Monitoring these other critical factors helps provide assurance that every unit of product has received at least the same treatment lethality as the units that were selected for internal temperature monitoring. However, your HACCP plan is insufficient because it does not include the monitoring of any such factors. We suggest that in order to determine which factors affect the rate of heating, you conduct a scientific study which includes a temperature distribution study of the heating system to identify cold spots, a heat penetration study that accounts for the slowest heating product under the worst case heating conditions, and identification of any other critical factors that affect the rate of product heating. The limits for these factors should be determined and included in your critical limit for your cook step, and your monitoring procedure should include monitoring these factors.
Data from two (b)(4) studies dated September 21, 2006, for crab Rangoon and April 9, 2009, for shrimp and vegetable egg rolls were collected during the inspection. Both these studies showed irregular heating in the oil and in the (b)(4) probes that measured product temperature.
In addition, during the inspection a deviation in cook temperature monitoring was observed when an egg roll tested did not achieve (b)(4) °F after the cook step. Affected product was destroyed and the corrective action record, “(b)(4),” dated November 5, 2013, lists changing the fryer settings and monitoring the belt speed as corrective actions. Your own investigation concluded the need to control and monitor fryer settings, including the fryer belt speed, thus revealing the necessity for one or more additional critical limits at this step, with appropriate monitoring procedures.
We acknowledge that the materials provided with the December 27, 2013, letter includes a study from your consultant, entitled, “(b)(4)” and dated December 24, 2013. The study concludes that adequate L. monocytogenes lethality occurred for the products described on the production dates indicated. The study also mentions that your process includes variables such as frying oil temperature, quantity of product and its temperature, and belt speed. The study uses a historical review of data which is not equivalent to a validation study using heat distribution and heat penetration data. As a result, the study does not provide sufficient information to identify all of the critical factors that have an effect on the rate of process heating, or establish limits for those factors.
Your firm’s response letter also included studies performed in-house using historical data that included temperature readings of shrimp egg rolls and crab rangoon after frying, when cooked at varying oil temperatures with varying fryer dwell times. However, although your studies concluded that your HACCP plan’s critical limit of (b)(4) °F for (b)(4) seconds was met for the products studied, your revised HACCP plan does not incorporate these factors into your critical limit or monitoring procedures.
3. 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 revised HACCP plan for shrimp egg rolls and crab rangoon lists a monitoring frequency at the labeling critical control point, “at least (b)(4) per production hour,” that is not adequate to control undeclared allergens.
We recommend that your frequency include monitoring the labels prior to start of production, as well as on an hourly basis thereafter.
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.
Additionally, we note that although the hazard analysis provided with your response letter identifies the hazards of pathogens, metal inclusion, and allergens as hazards that are reasonably likely to occur, these hazards are not listed in your HACCP plan for shrimp egg rolls and crab rangoon in accordance with 21 CFR 123.6(a) and (c)(1). We recommend that you list these hazards with the corresponding critical control points.
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.
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 reinspection-related costs. A reinspection 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. Reinspection-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 reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please submit your response to Seri Essary, Compliance Officer, at the above letterhead address. If you have any questions please contact Ms. Essary at (214) 253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
CC Stuart L. Swiggett, Senior Director, Manufacturing Operations
The Schwan’s Food Company
612 Georgia Avenue
Deer Park, TX 77536