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  5. Lanter Distributing LLC - 01/13/2015
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WARNING LETTER

Lanter Distributing LLC Jan 13, 2015

Lanter Distributing LLC - 01/13/2015


Recipient:
Lanter Distributing LLC


United States

Issuing Office:
Atlanta District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309

 

January 13, 2015
 
VIA UPS
 
Bill Behrmann, President/CEO
Lanter Distributing, LLC
3 Caine Drive
Madison, IL 62060
 
WARNING LETTER
(15-WL-06)
 
Dear Mr. Behrmann:
 
We inspected your seafood processing facility, located at 296 Southfield Parkway in Forest Park, GA on October 21-23, 2014.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 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 refrigerated, ready-to-eat seafood productsare adulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay 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 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 receive, store, and distribute to determine whether there are food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). Your firm distributes refrigerated, ready-to-eat seafood products, including various seafood spreads and dips, which according to your firm’s operations manager, may be stored in your firm’s coolers for up to (b)(4). Your firm failed to have a HACCP plan in place to control the pathogen hazard associated with the refrigerated seafood products you routinely receive, store, and distribute. 
 
2.      You must monitor sanitation conditions and practices during processing, as appropriate to your firm’s operations, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor for, at minimum, 1) the protection of food, food packaging material, and food contact surfaces for adulteration; 2) the proper labeling, storage, and use of toxic chemicals; 3) the exclusion of pests, and/or any other sanitation conditions and practices pertinent to your firm’s specific operations.
 
3.      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). Your firm’s operations manager verbally confirmed that there is currently no one associated with your firm that has completed the required HACCP training or is HACCP-qualified through job experience.
 
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 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.
 
A copy of the FORM FDA 483, Inspectional Observations, has been enclosed for your review.   This FDA 483 and this letter may not list all the violations at your facility. You are responsible for ensuring that all of your processing plants operate in compliance with the Act, the seafood HACCP regulations (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 U.S. Food and Drug Administration, Attention: Lakisha N. Morton, Compliance Officer, 60 8th Street NE, Atlanta, GA 30309. If you have questions regarding any issues in this letter, please contact Mrs. Morton at 404-253-1285.
 
Sincerely,
/S/ 
Ingrid Zambrana
District Director
Atlanta Office
 
 
cc:
Adam M. Behrmann, Operations Manager
Lanter Distributing, LLC
296 Southfield Parkway
Forest Park, GA 30297-2520