| Public Health Service Food and Drug Administration |
| Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771 |
Department of Health and Human ServicesWARNING LETTER
CIN-10-115588-23
Via United Parcel Service
September 21, 2010
Michael R. Riley, President
Rohr Fish, Inc.
123 Wabash St.
Toledo, OH 43604
Dear Mr. Riley:
We inspected your seafood processing facility, located at 123 Wabash St., Toledo, OH 43604 on April 19,21,22,27 - 30 and May 3 - 5,7,18, 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 offish 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 canned pasteurized crab meat, vacuum packed smoked fish, histamine forming fish, non histamine forming fresh fish and ready to eat seafood salad and dip 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 are as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits, which 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 plans list critical limits which are not adequate at the Receiving and Storage critical control points as follows:
A. Vacuum Packed Smoked Fish - Your HACCP Plan establishes a critical limit at the "Receiving" and "Storage" critical control points of 45° F ["Maintain Temp. at 45° or below"; "Maintain Temperature at or below 45° F if Fresh at or below 0° if frozen" respectively]. A temperature critical limit of 45° F does not ensure the control of the Clostridium botulinum hazard that you identified in your plan. Strict temperature control (i.e. at or below 40° F) during storage and distribution must be maintained to prevent pathogen growth and toxin formation by C. botulinum.
B. Ready to Eat (seafood) Salads and Dips - Your HACCP Plan establishes a critical limit at the "Receiving" and "Storage" critical control points of 45° F ["Maintain Temps at or below 45°"]. A temperature critical limit of 45° F does not ensure the control of the pathogen growth hazard you identified in your plan. Temperature control (i.e. at or below 40° F) during storage and distribution must be maintained to prevent pathogen growth.
2. 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, your firm's HACCP plans list monitoring procedures and frequencies at the "Receiving" and "Storage" critical control points that are not adequate as follows:
A. Vacuum Packed Smoked Fish
i. Your HACCP plan lists a monitoring procedure, "Take temperature of product off the delivery truck," at the Receiving critical control point that is not adequate to control C. botulinum toxin formation. Because you receive refrigerated vacuum packed smoked fish products that are not packed on ice or chemical coolants, from firms where transit times are expected to be extensive (e.g. greater than four (4) hours), temperature checks alone do not ensure product was continuously maintained below the critical limit while in transit. To ensure safe temperatures during transit, FDA recommends use of digital time/temperature data logger for continuous product internal temperature or ambient air temperature monitoring in your delivery trucks.
ii. Your HACCP plan lists a monitoring procedure, "Visually check temp of cooler and or freezer," and a frequency "3 times daily," at the Storage critical control point that are not adequate to control (C. botulinum) toxin formation. For refrigerated storage, FDA recommends continuous monitoring of cooler temperatures by a digital time/temperature data logger or recorder thermometer with visual check of the instrument at least once per day.
B. Ready to Eat (seafood) Salads and Dips-
i. Your HACCP plan lists a monitoring procedure, "Check temp outside container upon arrival" with a "Stem thermometer check" at the Receiving critical control point that is not adequate to control pathogen growth. Checking the temperature of the outside of the container using a stem thermometer does not ensure that product has been maintained below the critical limit while in transit for extensive time periods (e.g. greater than four (4) hours). To ensure safe temperatures during transit, FDA recommends use of digital time/temperature data logger for continuous product internal temperature or ambient air temperature monitoring in your delivery trucks.
ii. Your HACCP plan lists a monitoring procedure, "Check temp of cooler 3 times daily," and a frequency, "3 times daily" at the Storage critical control point that is not adequate to control pathogen growth. For refrigerated storage, FDA recommends continuous monitoring of cooler temperatures by a digital time/temperature data logger or recorder thermometer with visual check of the instrument at least once per day.
Specifically, the inspection revealed that your weekly operations end around 4:00 PM and do not resume until 7:00 AM the next morning. During this time span of approximately 15 hours, refrigerated cooler storage temperatures are not monitored. Additionally, your firm operates for half days on Saturdays, and does not operate on Sundays or holidays. Your cooler is not equipped with a continuous temperature monitoring device. Intermittent temperature monitoring cannot provide an equivalent safety assurance that unsafe temperature conditions have not occurred between those intermittent checks.
3. You must implement the monitoring procedures and frequencies 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 and frequencies at the Receiving and Storage critical control points to control the food safety hazards listed in your HACCP plans:
A. Histamine Producing Fish
i. Your HACCP plan for Histamine Producing Fish lists a monitoring procedure at the "Receiving" critical control point of "Visual: check ice Take temp. w/probe thermometer" "Open boxes upon receiving open your eyes Hold probe next to fish" at a frequency of "Every shipment."
ii. Your HACCP plan for Histamine producing fish lists a monitoring procedure at the "Storage" critical control point of "Store on ice Keep at or below 40° F" "check temp of storage TID and ice daily" at a frequency of "T.I.D."
B. Canned Pasteurized Crab Meat
i. Your HACCP plan for Canned Pasteurized Crab Meat lists a monitoring procedure at the "Receiving" critical control point of "Visual for ice and/or temperature taken" at a frequency of "every shipment."
ii. Your HACCP plan for Canned Pasteurized Crab Meat lists a monitoring procedure at the "Storage" critical control point of "Visually check for Ice or record temperature TID" at a frequency of "Daily T.I.D."
You stated during the inspection that in practice you never open boxes of any fish products, to include fresh histamine producing fish or canned pasteurized crab meat, received by your company as a cross docking operation, to verify adequacy of ice. You also do not take temperature of these fish products using a probe thermometer and there is no in-transit continuous temperature monitoring device used. Furthermore, your firm is not documenting the ice or temperature check conducted on fresh histamine producing fish received for processing by your firm.
C. Ready-to-Eat Salads and Dips
Your HACCP plan for Ready to Eat Salads and Dips lists a monitoring procedure at the "Storage" critical control point of "Check temp in cooler 3 times daily" at a frequency of "3 times daily."
D. Vacuum Packed Smoked Fish
Your HACCP plan for Vacuum Packed Smoked Fish lists a monitoring procedure at the "Storage" critical control point of "Visually check temp of cooler and or freezer" at a frequency of "3 times daily."
The inspection revealed that your weekly operations end around 4:00 PM and do not resume until 7:00 AM the next morning. During this time span of approximately 15 hours, refrigerated cooler storage temperatures are not monitored. Furthermore, your firm only operates until approximately 12:00 PM (noon) on Saturdays and is not operational on Sundays or holidays preventing the implementation of monitoring activities on those days. Your HACCP Plans lists storage monitoring procedures that require physical presence at the facility to implement.
Additionally, where ice checks have been identified as a method of monitoring the critical control point for storage, you have stated the activity is not documented. There is no record of this monitoring activity; therefore, it cannot be verified that the monitoring activity is being implemented by your firm.
4. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). Corrective action plans must ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation, and that the cause of the deviation is corrected. All of your HACCP plans list "Hold & Evaluate" as the corrective action to be taken if a deviation from any of your established critical limits occur. These steps do not ensure the cause of the deviation is corrected. Additionally, your corrective action plans do not fully describe the steps to be taken, responsibility for taking the steps and what your evaluation will be based on (for example: total time/temperature exposure).
5. 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 perform affirmative steps for refrigerated and frozen yellow lake perch, walleye, whitefish, and pike perch received from Great Lakes Fish Corporation, Wheatley, Ontario, Canada.
We acknowledge receipt of your response dated June 10, 2010, responding to the FDA-483 issued on May 18, 2010. Your response is inadequate in that it fails to include documentation of implemented HACCP corrections (e.g., revised HACCP plans, HACCP and sanitation monitoring records). FDA will verify the adequacy of your implemented corrections during our next inspection.
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 that your corrections are implemented adequately. 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 Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Ms. Hunter at 513-679-2700, Ext. 134, or at allison.hunter@fda.hhs.gov.
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District
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