- MC Fish Co
- Issuing Office:
- Cincinnati District Office
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Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
April 18, 2018
WARNING LETTER 552661
UNITED PARCEL SERVICE
Delivery Signature Requested
Michael L. Dye, Owner
MC Fish Company
112 Ferry Street
Milton, Kentucky 40045-8244
Dear Mr. Dye:
We inspected your seafood processing facility located at 112 Ferry St., Milton, Kentucky on March 20-23, 2018. We found you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations
(CFR), Part 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 United States Code
§ 342(a)(4). Accordingly, your paddlefish meat and paddlefish roe is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 Internet home page at www.fda.gov.
A Form FDA 483, Inspectional Observations (FDA 483), listing the deficiencies found, was issued to your firm on March 23, 2018.
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 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 plans for paddlefish meat and paddlefish roe do not list the food safety hazard of allergens. The allergen hazard is reasonably likely to occur because paddlefish is a fin-fish, one of the eight major food allergens.
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 paddlefish roe lists a critical limit, “SALT/ROE RATIO (concentrations),” at the Salting critical control point that is not adequate to control Clostridium botulinum. To fully control the hazard, your critical limit must identify minimum and maximum values to which a parameter can be monitored to ensure you achieve a minimum 5% water phase salt in the finished product.
3. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan to comply with 21 CFR 123.6. However, your firm did not follow the monitoring, record keeping, and verification procedures and frequencies listed in your HACCP plan for paddlefish roe.
a. You failed to monitor the thermometer in your packaged roe refrigerator for your refrigeration critical control point to control Clostridium botulinum. Your monitoring requirement includes two visual checks per day to ensure the temperature remains at or below 38ºF. However, in January 2016 your firm acquired and implemented a continuous temperature chart recorder for the packaged roe refrigerator and you no longer conduct and record daily checks. Furthermore, the continuous monitoring chart only reports temperatures in Celsius and you stated you did not know what your critical limit would be in Celsius. Also, for the month of December 2017, you only used the continuous recorder for the week of December 20 through December 26 when production took place from December 3rd through December 24th, 2017.
b. You failed to perform verification procedures for your refrigeration critical control point to ensure the temperature remains at or below 38ºF to control Clostridium botulinum. Per your HACCP plan, the temperature measuring device used to monitor the temperature inside the packaged paddlefish roe refrigerator should be calibrated annually; however, the temperature chart recording device you have been using since January 2016 has never been calibrated.
c. You failed to monitor the water phase salt (WPS) content for your salting critical control point to control Clostridium botulinum. Your salting critical control point lists a critical limit of “SALT/ROE RATIO (concentrations)” which you describe as 5% WPS content of finished paddlefish roe product. Per your HACCP plan, this limit is to be monitored on each batch; however, you have not performed this test for any batch you have produced.
d. You failed to perform verification procedures for your salting critical control point to ensure your salting process achieves at least a 5% water phase salt (WPS) content to control Clostridium botulinum. Per your HACCP plan, the salting critical control point lists finished product WPS analysis by an outside laboratory is to be completed annually and the scales used to weigh roe and salt are to be calibrated at least annually as verification procedures. You did not have finished product WPS analysis conducted during the 2016-2017 processing season and you acquired a new scale in December 2017 that has yet to be calibrated.
4. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not follow any monitoring, record keeping, and verifications procedures for the processing critical control point to control pathogenic growth and toxin formation listed in your HACCP plan for paddlefish meat.
This letter is not intended to be an all-inclusive list of deficiencies in your plant. It is your responsibility to ensure all of your products comply with the Act, the Seafood HACCP regulations (21 CFR part 123), and other applicable regulations.
This letter acknowledges the receipt of your firm’s response dated April 10, 2018 to the Form FDA 483 issued on March 23, 2018. We have determined your response is inadequate. You have not provided evidence such as updated HACCP records, calibration records, testing records or other documentation to show you have corrected any of the violations observed.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action such as seizure or injunction.
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
In addition to the above violations, your verification procedures do not include, at a minimum, reassessment of the HACCP plan whenever modifications to the process are made, as required by 21 CFR 123.8(a)(1). In January 2016, you implemented a continuous temperature monitoring device for the paddlefish roe refrigerator; however, your HACCP plan for paddlefish roe was not updated to reflect this change. The first page of your HACCP plan for paddlefish roe indicates the plan was reviewed and signed on January 3, 2016, and again on November 5, 2017. We advise that your HACCP plan reflects your current processes and procedures.
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 re-inspection-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 re-inspection related costs.
Your response should be sent to Zada L. Giles, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Dr., Suite 500, Nashville, TN 37217. If you have questions regarding the content of this letter, please contact Ms. Giles at (615) 366-7985 or Zada.Giles@fda.hhs.gov
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations-East