Inspections, Compliance, Enforcement, and Criminal Investigations
Lakeview Farms, Inc. 09-Nov-06
Department of Health and Human Services
Public Health Service
Cincinnati District Office
November 9, 2006
VIA FEDERAL EXPRESS
Earnest E. Graves, President and CEO
Lakeview Farms, Inc.
229 E. 2nd St.
Delphos, OH 45833
Dear Mr. Graves:
We inspected your seafood processing facility, located at Gressel Dr., Delphos, OH on June 20-30, 2006. 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, 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 various seafood 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:
l. 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 crab-style cheeseballs does not list the food safety hazard of Clostridium botulinum toxin formation.
This product is packaged in a modified atmosphere and appears to rely on pH as a secondary barrier (in addition to refrigeration) to prevent Clostridium botulinum toxin formation. We believe that the processing step should be a Critical Control Point, Clostridium botulinum toxin. formation should be identified as a food safety hazard and you should set a Critical Limit of pH< 5.0. As an alternative you could apply a time temperature integrator (TTI) to each container of finished product. Since you already monitor pH, we recommend the pH strategy over the TTI.
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 crab-style cheeseballs lists a critical limit (i .e., 42°F) at the temperature critical control point that is not adequate to control pathogens. FDA recommends a storage temperature of 40°F or below to control pathogens.
3. 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 123.6(c)(4). However, your firm's HACCP plan for crab-style cheeseballs lists a monitoring procedure at the storage critical control point that is not adequate to control pathogens growth and toxin formation. Intermittent temperature monitoring (i.e., daily as listed in your plan) is inadequate to assure that the crab-style cheeseballs are held at consistently safe temperatures throughout storage. The cooler storage temperature should be monitored by some continuous method. If you have a method in place for continuously monitoring storage temperatures, your plan should be corrected to reflect the method. In addition, you should monitor the temperature records at least once a day to assure that your critical limit is not exceeded.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for the crab-style cheeseballs at the storage critical control point to control pathogens is not adequate. Specifically, your plan does not address what action to take regarding the product involved in a critical limit deviation. Also, it does not address correcting the problem that caused the critical limit deviation (for example, repairing the storage cooler or adjusting the temperature).
5. You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical control limit of 42°F for crab-style cheeseballs at the storage critical control point to control pathogens.
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. We note that the name of your product, "crab-style cheeseball," is not an existing common or usual name for a food. In the absence of an existing common or usual name, 21 CFR 101.3(b)(3) requires your product to bear a statement of identity that appropriately describes the food. The name "crab-style cheeseball" does not appear to appropriately describe this food. If the food is an imitation crabmeat spread, it may be identified as such. If the food is a crab meat substitute spread, it may be identified as such. Or, if the food is a crab flavored seafood spread, it may be identified as such.
We note that in the "Contains" statement you provide the name of the food source for each of the major food allergens that are listed in the ingredient statement (milk, egg, wheat, soy, Pollock, Cod) except for the fin fish "anchovies." We recommend that you also include "anchovies" within the "Contains" statement.
We also note that the ingredient statement includes the collective terms "and" and "and/or" for several of the ingredients. In accordance with the requirements of 21 CFR 101.4 there are only a few exceptions to the requirement that the ingredients must be individually listed in descending order of predominance. While this product may qualify for the fish protein exception in 21 CFR 101.4(b)(23) that allows for "and/or" labeling, the fish ingredients are not declared in accordance with this exception.
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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have questions regarding any issues in this letter, please contact Ms. Sego at (513) 679-2700 extension 164.
Carol A. Heppe