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Department of Health and Human Services
WARNING LETTER
11-PHI-14
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
June 14, 2011
Ms. Cheri L. Dodge, Owner/President
Culinary Crossing Inc.
287 Maple Ave.
Harleysville, PA 19438-1742
Dear Ms. Dodge:
We inspected your seafood processing facility located at 287 Maple Ave., Harleysville, Pennsylvania, on February 23, 2011 to March 7, 2011. 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 and 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 Seafood Soups 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 on 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 have a HACCP plan that, at a minimum, lists the appropriate critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). However, your firm’s HACCP plan for “Fully cooked, not shelf stable seafood products” that covers all of your refrigerated seafood soups and chowders, does not list a critical control point to control Clostridium botulinum growth and toxin formation.
Clostridium botulinum growth and toxin formation is a reasonably likely hazard for your products because they are packaged in oxygen impermeable packaging materials. Moreover, your plan lists the hazard of “toxin production” and references a storage temperature of 38°F, which is the recommended temperature for storing refrigerated products packed in oxygen impermeable materials when there are no secondary barriers to Clostridium botulinum toxin formation. With regard to secondary barriers, please be advised that your plan may control the hazard of toxin formation either through formulation of your products or through another method that provides an equivalent measure of safety. Currently, the only alternative method FDA is aware of is the use of time temperature integrators for refrigerated products where there is no secondary barrier. Specifically,
- When using product formulation to control Clostridium botulinum growth and toxin formation in refrigerated products, FDA recommends that the formulation of your finished product should achieve either a water activity below 0.97, a pH of 5.0 or below, water phase salt level of 5% or more, or a combination of pH, salt, and/or water activity that when combined prevent the growth of Clostridium botulinum type E and non-proteolytic types B and F. Products with these types of barriers may be safely held at 40°F or below.
- Time and temperature integrators are a control other than formulation control that you may adopt as a secondary barrier in addition to refrigeration. When adopting a strategy that includes the use of time/temperature indicators (TTIs), a TTI must be affixed on each individual package of soup. In addition, when there is no formulation control and TTIs are the strategy associated with control of toxin formation, strict temperature control is necessary at or below 38°F throughout all storage periods and product distribution in order to ensure the safety of the products.
We acknowledge that your new HACCP Master Plan for Fully Cooked, Not Shelf Stable Seafood Products and your response to the FDA 483 indicate that you have purchased and are using the appropriate equipment. We request documentation to support that you have installed and are appropriately using equipment capable of providing continuous monitoring and recording of your coolers.
For additional information related to the hazard of Clostridium botulinum, please refer to the Chapter 13 of the current, 4th Edition, of the Fish and Fisheries Products Hazards and Controls Guidance.
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 “Fully cooked, not shelf stable seafood products” that covers all of your refrigerated seafood soups and chowders does not list a critical limits at the “CCP 1B Internal Temperature of Products Cooked in the Kettle” critical control point to control pathogen reduction/survival. Specifically, your plan does not include critical limits necessary for ensuring the safety of the cook process. These may include cook time, batch size, portion control and/or soup formulation. The cook process should be established by a study to verify that the cooking process is adequate, on a repeated basis, for each batch of soup.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of decreasing the internal temperature from (b)(4) at the critical control point to control CCP 2B as listed in your HACCP plan for your seafood soup products. Of the (b)(4) Cooling Reports reviewed during the inspection, (b)(4) lacked documentation that a seafood soup cooled from (b)(4).
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 your seafood soups at the “Internal Temperature of the Products Cooked in the Kettle (cooling step) CCP 2B” and the “Storage Temperature CCP3B” critical control points are not adequate to control “toxin formation”. In addition, the “Allergen Statement CCP 4” critical control point is not adequate to control undeclared allergens. Specifically for the cooling and storage critical control points, your firm failed to include product evaluation or disposition of the product, when necessary. For the allergen critical control point, your listed corrective action of “alternate strategy for corrective actions” is not appropriate in that this action does not prevent potentially unsafe product from entering commerce and does not correct the cause of deviation.
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 temperature critical limits at your storage critical control point on 9/6/10, 11/25/10 and 11/26/10. The Fahrenheit Temperature Record entries indicate that the temperature alarm was activated, but no corrective actions were documented.
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 the safety of water, the prevention of cross-contamination from insanitary objects and the proper labeling, storage and use of toxic chemicals with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. Safety of water that comes into contact with food or food contact surfaces, including water used in the manufacture of ice as evidenced by possible microbiological concerns with dead legs in water lines. [ 21 C.F.R. § 123.11(b)(1)];
b. Prevention of cross-contamination from insanitary objects as evidenced by the fact that jackets were hanging from shelving where food was also stored. [ 21 C.F.R. § 123.11(b)(3)];
c. Proper labeling, storage and use of toxic chemicals as evidenced by a jug of sanitizer being stored adjacent to spices and syrups on a shelf in the preparation room. [21 C.F.R. § 123.11(b)(6)].
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 123], the Current Good Manufacturing Practice regulation [21 CFR 110], and Food Labeling regulation [21 CFR 101]. 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 Food and Drug Administration, Attention: Compliance Officer Yvette Johnson, at the address indicated on the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Johnson at (215) 717-3077 or Yvette.Johnson@fda.hhs.gov.
Sincerely,
/S/
Kirk Sooter
Director
Philadelphia District
cc:
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director, Bureau of Food Safety and Laboratory Services
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