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Department of Health and Human Services
WARNING LETTER
11-PHI-22
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
September 23, 2011
Beau J. Heeps, President
K. Heeps, Inc.
5239 Tilghman Street
Allentown, PA 18104
Dear Mr. Heeps:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 721 N 17th Street, Allentown, PA on August 17, 2011 through August 29, 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 (21 CFR 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 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 “Not Fully Cooked Not Shelf Stable - Frozen Fish Puree” (fish puree), fresh and/or frozen “broiled or flash fried crab cakes”, “flash fried flounder”, “parmesan crusted tilapia”, “jumbo coconut shrimp”, “jumbo shrimp”, “lobster mashed potatoes”, and “flash fried crab cake nugget” 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, FDA regulations, the Fish and Fisheries Product Hazards & Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.
Your significant violations were as follows:
Seafood HACCP
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 fresh and/or frozen “broiled or flash fried crab cakes”, “flash fried flounder”, “parmesan crusted tilapia”, “jumbo coconut shrimp”, “jumbo shrimp”, “lobster mashed potatoes”, and “flash fried crab cake nugget” to control the food safety hazard of undeclared food allergens on finished product labels. FDA recommends that controls be in place to assure that the presence of these ingredients (i.e. wheat, soy, milk, crustaceans, and fish) are declared accurately on finished product labels.
Please be advised that in accordance with 21 CFR 123.6(b)(2) your firm may group kinds of fish and fishery products together, or group kinds of production methods together if the food safety hazards, critical control points, critical limits, and procedures identified are identical for all fish and fishery products so grouped or for all production methods so grouped.
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 (CCPs), to comply with 21 CFR 123.6(a) and (c)(2). A CCP 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 “Fish Puree” does not list the CCP of packaging/labeling for controlling the food safety hazard(s) of C. botulinum and undeclared allergens.
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 (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 “Fish Puree” does not list the food safety hazard of undeclared allergens and pathogen growth and toxin formation. Your plan currently lists a food safety hazard of (b)(4) However, this product poses a risk for undeclared allergens; and pathogen growth and toxin formation. Specifically,
A. “Fish Puree” contains the ingredients, “pollock and/or hoki, soybean oil, and whey protein concentrate.” Fish, soy, and milk are several of the most common food allergens. HACCP plans for fishery products that contain these ingredients should list and control the hazard of undeclared allergens. For additional information related to the hazard of undeclared allergens, please refer to Chapter 19 of the current, 4th Edition, of the Fish and Fisheries Products Hazards & Controls Guidance (the Guide).
B. “Fish Puree” is packaged with an oxygen restrictive film, therefore FDA recommends that you implement a barrier to C. botulinum toxin formation by including cooking instructions on the product label that state “Do Not Defrost”, in conjunction with keeping the product in a frozen state throughout distribution. FDA recommends that you remove the statement “For best results, cook from a frozen state”.
4. 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,
A. Your HACCP plan for “Fish Puree” does not list adequate critical limits (CLs) at the “cooling” critical control point, (which you call CCP #9) to control “pathogen growth and toxin formation, specifically for B. cereus and S. Aureus. Your listed critical limit states (b)(4) This critical limit does not ensure that the product is properly cooled because it does not include any cooling times or temperatures. FDA recommends that “exposure time (i.e., time at IT above 50Ëš F but below 135Ëš F) should be limited to 4 hours, as long as no more than 2 of those hours are between 70Ëš F and 135Ëš F.”
5. 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,
A. Your firm’s HACCP plan for “Fish Puree” lists inadequate monitoring procedures at the ”Cooling (CCP #9)” critical control point to control the hazard of “pathogen growth and toxin formation, specifically for B. Cereus and S. Aureus”. Your listed monitoring procedures state that your firm will monitor the (b)(4) however your HACCP plan does not list those time/temperatures as critical limits. FDA would recommend monitoring the temperatures from 120Ëš F to 50Ëš F. Further, the method of monitoring does not fully explain how you will monitor the product and the monitoring frequency references only taking the temperature (b)(4) The monitoring frequency reflected in your plan is inadequate to control the hazard of pathogen growth and toxin formation. Monitoring of cooling temperatures, for all batches, needs to be frequent enough to ascertain if the product(s) were time/temperature abused.
6. 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 overall, does not identify the deviations or how you will correct the cause of the deviations. In addition, your plan does not state how to prevent distribution of potentially unsafe products. When amending your HACCP plans, you should ensure that your corrective actions accomplish both correcting the cause of the deviations and preventing potentially adulterated products from entering into commerce.
This letter is not intended to be an all-inclusive list of violations. You are responsible for ensuring that your overall operation and the food you distribute comply with the Act and its implementing regulations. You should take prompt action to correct the violations described in this letter and establish and implement procedures which will prevent them from occurring in the future. Failure to take appropriate corrective action may result in enforcement action without further notice, such as seizure or injunction.
You should notify this office in writing within fifteen (15) working days of receiving this letter of the current status of your corrective actions. Your response should include each corrective action that you have or will take to correct the violations described above, and in particular, what methods and controls you will implement to prevent their recurrence. Please include copies of any documentation that demonstrates the corrections have been implemented. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and the time frame in which they will be completed.
Your written response should be sent to Lynn S. Bonner, Compliance Officer, at the address noted above. If you have questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by e-mail at Lynn.Bonner@fda.hhs.gov
Sincerely,
/S/
Kirk D. Sooter
District 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, Director, Bureau of Food Safety and Laboratory Services
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