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WARNING LETTER

Manns Fish Market MARCS-CMS 525533 — Jun 20, 2017

Manns Fish Market - 525533 - 06/20/2017


Delivery Method:
UPS

Recipient:
Recipient Name
John A. Mann
Manns Fish Market

1249 E 20th St

Caruthersville, MO 63830-9278
United States

Issuing Office:
Kansas City District Office

United States


 

  

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Office of Human and Animal Food West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

 

 
 
WARNING LETTER
 
 
VIA UPS
 
June 20, 2017
 
John A. Mann, Owner
Mann’s Fish Market
1249 E 20th St
Caruthersville, MO 63830-9278
 
Reference: CMS # 525533
 
Dear Mr. Mann:
 
We inspected your seafood processing facility, located at 1249 E 20th Street, Caruthersville, MO on May 18-19, 2017. 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. 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 paddlefish and paddlefish 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, the seafood HACCP regulation and FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products can be found on our web site athttp://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm
 
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 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). Your firm’s hazard analysis has not identified food safety hazards that are reasonably likely to occur and does not have a HACCP plan for your paddlefish and paddlefish roe products to control food safety hazards which may include pathogen growth and environmental chemicals/pesticides. In addition, the plastic containers holding the paddlefish and paddlefish roe products could allow for a reduced oxygen environment conducive to Clostridium botulinum growth and toxin formation as a result of time and temperature abuse.
 
Once you have created a HACCP plan for your paddlefish and paddlefish roe products, FDA recommends that you adequately monitor the processing and storage of your paddlefish and paddlefish roe products by continuously monitoring your processing and storage temperatures.
 
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).
 
2.    To comply with 21 CFR 123.10, you must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who may otherwise be qualified through job experience to perform the following functions: (1) the development of the HACCP plan, as required by 21 CFR 123.6(b); (2) the reassessment and modification of the HACCP plan in accordance with the corrective action procedures specified in 21 CFR 123.7(c)(5); (3) the reassessment and modification of the HACCP plan in accordance with the verification activities specified in 21 CFR 123.8(a)(1);(4) the reassessment and modification of the hazard analysis in accordance with the verification activities specified in 21 CFR 123.8(c); and (5) perform the record review required by 21 CFR 123.8(a)(3).
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
(b) (3) (A)
 
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 overall operation and the products you distribute are in compliance with the law.
 
(b) (3) (A)

 

Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. In your response please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and their adequacy. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Please send your reply to the Food and Drug Administration, Attention: Jessica Hensley, Compliance Officer, at the address listed in the heading of this letter. If you have questions regarding any issue in this letter, please contact CO Hensley at (913) 495-5183 or Jessica.hensley@fda.hhs.gov.
  

Sincerely,
/S/
Cheryl Bigham
Program Division Director