Rushing Waters Fisheries, LLC 8/27/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
August 27, 2013
via UPS Overnight Delivery
Refer to MIN 13 - 21
Peter J. Fritsch
Rushing Waters Fisheries, LLC
Box H, Highway H Fire N301
Palmyra, Wisconsin 53156
Dear Mr. Fritsch:
We inspected your seafood processing facility located at N301 County Road H, Palmyra, Wisconsin, on April 25, 26, 30, May 2 and 8, 2013. 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 fresh trout, smoked trout fillets, smoked fish spreads, smoked salmon fillets, whole smoked salmon, marinated salmon fillets, and salmon burgers 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. Your HACCP plans do not list one or more critical control points (CCPs) that are necessary for each of the identified food safety hazards, to comply with 21 CFR 123.6(c)(2). Specifically,
A. Your HACCP plans for fresh trout and smoked trout fillets do not list a critical control point at the cutting step to control the hazard of metal inclusion.
B. Your HACCP plans for smoked trout fillets, smoked fish spreads, smoked salmon fillets, smoked salmon-whole and marinated salmon fillets do not list a critical control point at the packaging step, which is necessary to control the hazard of undeclared allergens.
C. Your HACCP plan for salmon burgers, in vacuum-packaged pouches, does not list a critical control point at the packaging step, which is necessary to control the hazard of undeclared allergens and Clostridium botulinum toxin formation during finished product storage in the freezer by labeling the products with a “keep frozen” statement.
2. Your HACCP plans do not list a critical limit that ensures control of one or more hazards, to comply with 21 CFR 123.6(c)(3). Specifically, your HACCP plans for smoked fish spreads, smoked trout fillets, smoked salmon-whole, and smoked salmon fillets list a critical limit at the cooler storage CCP of “MAX AIR TEMP OF (b)(4)F FOR (b)(4) HOURS,” which does not ensure control of Clostridium botulinum growth and toxin formation. Additionally, the hazard of pathogen growth should be listed if the product is not packed in reduced oxygen packaging.
3. You did not implement the monitoring, recordkeeping, and verification procedures listed in your HACCP plans, to comply with 21 CFR 123.6(b). Specifically:
A. Your HACCP plan for smoked salmon fillets lists the hazard of Clostridium botulinum at your cooking CCP. The monitoring procedure in the plan is listed as “Digital Temp Recorder” and “CONTINOUS EVERY BATCH.” For 4/11/13 your continuous temperature recording chart states that the temperature probe broke. An attached temperature record demonstrates that cook temperatures were taken manually every (b)(4) minutes. This monitoring procedure does not ensure that the critical limit of (b)(4)ºF for (b)(4) minutes was met.
B. Your HACCP plan for Smoked Trout Fillets lists the critical limit at the Brining CCP as “(b)(4) hour brine time at (b)(4) Salinity.” On 3/19/13 the brine time was not recorded on the HACCP brine log. Notes on the log indicated that the product was re-brined, but you did not maintain complete corrective action records because the re-brine time is not recorded. Additionally, corrective action records need to be reviewed, signed and dated by a HACCP-trained individual within seven days of the record being made. In this case, the corrective action record was initialed but not dated.
4. Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure the cause of the deviation was corrected, to comply with 21 CFR 123.6(c)(5). Specifically, your HACCP plan for smoked salmon fillets lists the corrective action at the cooking CCP as “If not (b)(4)°F for (b)(4) min Toss out product.” This corrective action addresses the product but not the cause of the deviation.
5. Your verification procedures do not include, at a minimum, ongoing verification activities including calibration of process monitoring instruments, to comply with 21 CFR 123.8(a)(2). Specifically,
A. Your HACCP plans for Smoked Salmon Fillets, Smoked Fish Spreads and Smoked Trout Fillets list a verification procedure at the Cooler Storage as “REVIEW MONITORING, CORRECTIVE ACTION, AND VERIFICATION RECORDS WITHIN 1 WEEK.” This verification procedure does not include the calibration of the temperature recording charts used to continuously monitor the air temperature of the cooler.
B. Your HACCP plans for Smoked Salmon Fillets and Smoked Trout Fillets list a verification procedure at the Cooking CCP as “REVIEW MONITORING, CORRECTIVE ACTION, AND VERIFICATION RECORDS WITHIN 1 WEEK.” This verification procedure does not include the calibration of the probes and temperature recording charts used to continuously monitor the temperature of the fish during the cooking step.
C. Your HACCP plan for Smoked Salmon Whole lists the verification procedure as “Manager Sign Off” at the Brining CCP, Cooking CCP and Cooler Storage CCP. This verification procedure does not include the review of monitoring and corrective action records within one week, calibration of equipment or end product testing (water phase salt analysis).
6. You did not review your critical control point monitoring, calibration, and end-product testing records within one week and within a reasonable time after the records were made, to comply with 21 CFR 123.8(a)(3). Specifically, the Fresh Fish Cooler temperature recording charts and Smoked Fish Cooler temperature recording charts dated 12/26/12 - 1/8/13 and 8/28/12 - 9/18/12 were not reviewed, signed and dated within one week of the record being made.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
We acknowledge receipt of your undated, written response to the form FDA 483, Inspectional Observations, issued on May 8, 2013. Your response was received in our office on May 21, 2013. Your corrective actions do not fully address the concerns noted on the FDA 483 and in this Warning Letter, as detailed below:
483 Observation #1 (Warning Letter #1) – You did not provide a copy of all HACCP plans that required correction. Please ensure that all HACCP plans have been revised to address the applicable violations.
483 Observation #2 (Warning Letter #2) - Your revised HACCP plan for Smoked Salmon and Trout Spreads still lists Clostridium botulinum as a hazard at the Cooler Storage CCP. Since it is an aerobic environment, pathogen growth is a hazard instead of Clostridium botulinum.
483 Observation #6 (Warning Letter #4) – Please describe in more detail what changes were made to HACCP plans to address this violation. In HACCP plans provided with your FDA 483 response, corrective actions were not revised for Cooking CCPs.
483 Observation #7 (Warning Letter #5) - The HACCP plans provided with your FDA 483 response were not revised to include calibration of recording charts as a verification procedure at the Cooler Storage CCP. HACCP plans were also not updated to include calibration as a verification procedure at the Cooking CCP.
The implementation and effectiveness of the other corrective actions described in your FDA 483 response will be evaluated during our next inspection.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. In particular, please address the above-noted inadequacies in your written response to the FDA 483. 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) and the Current Good Manufacturing Practice regulation (21 CFR 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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Please send your reply to the Food and Drug Administration, Attention: Timothy G. Philips, Compliance Officer, at the address noted in this letterhead. If you have questions regarding any issues in this letter, please contact Mr. Philips at (612) 758-7133.
Michael Dutcher, DVM