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WARNING LETTER

Fort Massac Fish Market MARCS-CMS 496904 — Oct 04, 2016

Fort Massac Fish Market - 496904 - 10/04/2016


Delivery Method:
UPS

Recipient:
Recipient Name
Mary E. Parish
Fort Massac Fish Market

1117 E. 2nd Street

Metropolis, IL 62960
United States

Issuing Office:
Chicago District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

 
 

 

October 4, 2016
 
WARNING LETTER
 
CHI-1-17
 
 
VIA UPS NEXT DAY
SIGNATURE REQUIRED
 
Mary E. Parish, Owner
Fort Massac Fish Market
1117 E. 2nd Street
Metropolis, IL 62960
 
Dear Ms. Parish:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 1117 E. 2nd St., Metropolis, IL on April 5–8, 2016. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. However, you have not provided a response with corrections to those deviations. In accordance with 21 CFR 123.6 (b), failure of a processor of fish or fishery products to 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 ready-to-eat caviar, also known as paddlefish and hackleback roe, 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 and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.
 
Your significant deviations are 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 plan for caviar (i.e., “fish eggs (spoonbill & hackleback)”) does not list the hazard of Clostridium botulinum (C. botulinum) growth and toxin formation at the “Receiving Raw Roe” critical control point for roe packaged in plastic pails with lids and plastic bags. Roe in bulk quantities can become tightly packed, which displaces air within the packaging. This creates a reduced oxygen environment and introduces the hazard of C. botulinum. Because the packaged roe is transported in coolers with gel packs (i.e., cooling media), FDA recommends that you ensure there is an adequate quantity of cooling media that remains frozen to maintain product below 38°F throughout transit and the internal temperature of the product is below 38°F when received at the processing facility. Alternatively, you may choose to ensure that product is completely surrounded in ice to have maintained product below 38°F throughout transit when received at the processing facility.
  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 caviar (i.e., “fish eggs (spoonbill & hackleback)”) lists a critical limit of “putting (b)(4)-percent or better of water phase salt in each batch of eggs” at the “Salting Process” critical control point that is not adequate to control C. botulinum growth and toxin formation. To fully control the hazard, FDA recommends your critical limit for salting include the critical factors (e.g., ratio of salt to roe, time of brining, etc.) for the brining process needed to achieve a minimum 5% water phase salt in the finished product.
  3. You must implement the recordkeeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the “Refrigerated Storage” critical control point to control C. botulinum growth and toxin formation listed in your HACCP plan for caviar (i.e., “fish eggs (spoonbill & hackleback)”). Specifically, your firm’s monitoring procedure states “Continuous Recorder & Back Monitoring (b)(4) time a day by hand (b)(4)”. However, your firm did not have records indicating that you are checking the recorded data with a hand-held temperature device, (b)(4) times per day. Additionally, the investigator found the continuous temperature recording device not functioning properly; it showed temperatures constantly fluctuating from 8-18°F, while the dial temperature on the front of the cooler and digital readout on the chart recorder indicated a temperature of 33°F, demonstrating that the continuous temperature recording device was not accurate and should be repaired or properly calibrated.
  4. Because you chose to include a corrective action plan, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan for caviar (i.e., “fish eggs (spoonbill & hackleback)”) at the following critical control points are not appropriate, as you have not addressed the cause of the deviation.
    1. Your correction action plan for the “Receiving Raw Roe” critical control point lists “Refuse to Receive”. In addition to refusing the product, FDA recommends discontinuing use of the supplier until evidence is obtained that the supplier is not fishing from uncontaminated waters.
    2. Your corrective action plan for the “Salting Process” critical control point lists “(b)(4) and sample for water phase salt”. In addition to testing the water phase salt content, FDA recommends making the appropriate corrections to the brining process (i.e., adjust the salt concentration, or adjust the salt to roe ratio, etc.).
  5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110 to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, prevent cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, and exclusion of pests, as evidenced by the following:
    1. Roach-like insects too many to count were in the only restroom in the building. A cockroach-like insect crawled out from underneath a stack of pail lids sitting on the processing table, that are used to seal the finished product for shipping. A house fly-like insect and a wasp were observed in the processing room. Two ant-like insects were observed on the scale table.
    2. Three different family pet dogs have free access to the entire building including the processing room. The dogs were observed by our investigator in the employee break room and processing room.
    3. The food contact surfaces of screens and spatulas were not properly cleaned and sanitized prior to use. These items were observed being rinsed with only water prior to being used in the production of the raw ready-to-eat-caviar.
    4. The owner had direct bare hand contact with ready-to-eat finished product without cleaning or sanitizing her hands after touching tables and door handles.
    5. A person was observed eating food in the processing room. Additionally, aluminum and plastic beverage containers were observed in the processing room.
  1. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water that comes into contact with food or food contact surfaces, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests from the food plant, as required for the processing of your raw ready-to-eat caviar.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps that you are taking to correct these violations. You should include in your response documentation such as monitoring and data logger records, HACCP plan revisions, and any other information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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.
 
This letter may not list all the violations at your facility. As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your processing plant operates in compliance with the Act, and the seafood HACCP regulation (21 CFR Part 123). 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 reinspection-related costs from the responsible party of the domestic facility. 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)]. 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be addressed to:
 
Lauren Crivellone, Compliance Officer
FDA Chicago District Office
U.S. Food and Drug Administration
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661 
 
Refer to the Unique Identification Number (CMS Case #496904) when replying. If you have any questions about the content of this letter, please contact Ms. Crivellone via email at lauren.crivellone@fda.hhs.gov or by phone at (312)-596-4157.
 
Sincerely,
/S/
William R. Weissinger
District Director