Inspections, Compliance, Enforcement, and Criminal Investigations
CTI Foods, LLC 2/6/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
February 6, 2013
UPS OVERNIGHT MAIL
Robert Horowitz, President
CTI Foods, LLC
22303 Highway 95
Wilder, ID 83676-5096
Dear Mr. Horowitz:
We inspected your seafood processing facility, located at 504 Sansom Blvd. Saginaw, Texas on September 5 – 21, 2012. 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 lobster bisque, clam chowder and seafood gumbo soups are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay 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 received your firm’s response letter dated October 8, 2012 and the supporting documentation sent via email on November 26 and 27, 2012, and December 7 and 20, 2012 by Robert Roe, Director of Quality Assurance. We have reviewed all your documentation and find the following significant violations have not been addressed.
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(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 revised HACCP plan submitted December 20, 2012, does not list the critical control points (CCPs) of tempering (thawing) raw lobster, hot filling, container integrity and refrigerated finished product storage of the lobster bisque soup for controlling the food safety hazard of Clostridium botulinum.
Chapter 18 of the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance recommends implementation of a critical control point for hot filling and container integrity to control the introduction of pathogenic bacteria after specialized cooking processes. However, your revised HACCP plan does not address these issues.
Further, your firm thaws frozen reduced oxygen packaged raw lobster used in making your lobster bisque soup in the refrigerator with a temperature threshold of (b)(4)°F for (b)(4) hours. However, Chapter 13 of the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance recommends that refrigerated (not frozen) reduced oxygen packaged raw, unpreserved fish or unpasteurized, cooked fishery products be maintained at 38°F.
Your firm also stores your finished product lobster bisque soup in a cooler that has a threshold of (b)(4)°F. Chapter 12 of the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance recommends that you set critical limits for refrigerated (not frozen) storage or processing of the raw material, in-process product, or finished product of a cooler ambient air temperature of 40°F or below. You should take measures to ensure your storage cooler and refrigerator temperatures do not exceed the guidance recommended temperatures.
Additionally, your firm also manufactures and stores frozen clam chowder and seafood gumbo soups that have finished product labeling stating “Keep Frozen”. Your revised HACCP plan does not have a critical control point for review of the frozen finished product labeling to ensure control of the Clostridium botulinum hazard during storage.
Chapter 13 of the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance recommends that controls should be in place to ensure that frozen products in reduced oxygen packaging are immediately frozen and all finished product labels contain a “Keep Frozen” statement, and labeled to be held frozen until used and thawed under refrigeration immediately before use.
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 lobster bisque soup has a critical limit of (b)(4)°F for a minimum of (b)(4) minutes for the cook step critical control point. This time and temperature combination is not adequate to control Clostridium botulinum.
FDA recommends cooking to obtain an internal temperature of at least 185°F for 51.8 minutes for a 6 log inactivation of non-proteolytic Clostridium botulinum type B.
Other recommended time and temperature parameters can be found in Appendix 4, Table A-4, Inactivation of Non-proteolytic Clostridium botulinum type B, of the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance. Also once you have made corrections to your cooking critical control point you may need to make appropriate changes to your chilling CCP.
3. 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(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 the lobster bisque soup does not list the food safety hazard(s) of Clostridium botulinum, metal inclusion, undeclared allergens and food intolerance substances.
Specifically, your revised HACCP plan has the potential food safety hazard listed as “biological”. This does not comply with the regulations as noted above. You must identify the food safety hazards you are trying to control in your plan.
Also, due to your failure to identify the food safety hazards in your HACCP plan, you may need additional CCPs. You may also need to revise your current critical limits, monitoring, record-keeping, verification procedures, and corrective action plans, for your existing CCPs once you have identified all food safety hazards likely to occur.
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.
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 reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)).
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 send your reply to the Food and Drug Administration, Attention: Ronda Loyd-Jones, Compliance at 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact: Ronda Loyd-Jonesat 214-253-5242.
Reynaldo Rodriguez Jr.
Dallas District Director
cc: Scott Waltson, Vice President of Operations
CTI Foods LLC
504 Sansom Blvd., Saginaw, Texas 76179