Inspections, Compliance, Enforcement, and Criminal Investigations
Quality Plus Products, Inc. 9/22/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
September 22, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-31
Robert C. Jackson, President
Quality Plus Products, Inc.
4049 Deemer Road
Bellingham, Washington 98226
Dear Mr. Jackson:
We inspected your food processing facility, located at 4049 Deemer Road, Bellingham, Washington, on June 3, 4, 7, 8, and 9, 2010. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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, including the sanitation control procedures under 21 CFR 123.11, 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).
In addition, 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 refrigerated pickled herring, refrigerated pickled wild salmon, and refrigerated smoked salmon 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.
Your significant violations were 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have a HACCP plan for your refrigerated, ready to eat, pickled herring to control the food safety hazards of histamine formation and pathogen growth.
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 "Hot Smoked Salmon" does not list the critical control point of finished product cooler storage to control pathogen growth, including potential Clostridium botulinum growth and toxin formation.
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 "Hot Smoked Salmon:"
a. does not list a critical limit value for "fish thickness" at the "Brining" critical control point; and
b. does not list a critical limit associated with product temperatures during cooling at the "Cooling After Hot Smoking" critical control point. The plan lists "no more than (b)(4) hours between the end of the smoking process and placement of the product under refrigeration at a maximum cooler temperature of (b)(4)°F," however there are no temperature values for the product. For example, the Hazard Guide recommends cooling the product from 140°F to 70°F within 2 hours and cooling to 40°F within an additional 4 hours.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR Part 123.6(c)(4). However, your firm's HACCP plan for "Pickled Wild Salmon" does not list adequate monitoring procedures at the "Salting/Pickling" critical control point to control pathogen growth. Specifically, monitoring or checking temperatures with a thermometer "several times a day" as listed in your plan is not adequate to ensure proper temperatures are maintained between the intermittent checks. FDA recommends the use of equipment capable of continuously monitoring and recording time and temperature on a 24 hour a day/7day a week basis with a daily check of the temperatures and of the equipment.
In addition, we note that your firm provided a verbal commitment during the inspection to begin use of a continuous monitoring instrument to monitor the internal temperature of the fish during smoking of your hot smoked salmon product. Please be advised that FDA recommends monitoring at least 3 of the largest/thickest portions of fish, located in the coldest parts of the cooker during the smoking operation to ensure that the entire lot of product is properly smoked.
5. Because you chose to include corrective action plans in your HACCP plans for your "Hot Smoked Salmon," "Smoked Salmon Spread or Dip," and "Pickled Wild Salmon" your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans to control the hazards of Clostridium botulinum toxin production in finished product, pathogen growth and toxin production, and allergens are not appropriate as follows:
a. your listed corrective action plan for your hot smoked salmon product at the brining critical control point (CCP) does not describe the steps to be taken to ensure that affected product does not enter into commerce. For example, your firm may choose to reprocess (i.e., re-brine), or hold and evaluate the water phase salt levels, or divert or destroy the product, etc. use when a process deviations occurs;
b. your listed corrective action plan for hot smoked salmon at the cooling and refrigerated storage CCP does not describe the steps to be taken to ensure that the cause of the deviation is corrected; and
c. your listed corrective action plans for your pickled wild salmon at the finished product storage CCP and your smoked salmon spread or dip at the finished product storage CCP do not describe the steps to be taken to ensure that affected product is not entered into commerce or that the cause of the deviation is corrected.
6. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor 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 with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the observation of a packing employee using an unsanitary box cutter to open four vacuum packaged smoked salmon portions and then handling the fish in order to remove particles of ash adhering to the surface of the smoked fish.
7. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i); and you must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2(ii). However, your firm did not have products specifications and an affirmative step for the pickled herring processed by and imported from (b)(4) located in (b)(4).
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, 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.
In addition, please be advised that FDA conducted water phase salt (WPS) analyses on samples of your smoked salmon product collected during the inspection. The results of these analyses indicated a wide variation in the finished product WPS levels. We recommend that your firm perform quarterly WPS analyses to verify that your processes achieve adequate and consistent WPS levels in each lot of product.
Please send your written reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Elrand at (425) 483-4913.
Charles M. Breen