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WARNING LETTER

Florida Key West, Inc. MARCS-CMS 509508 —


Recipient:
Florida Key West, Inc.

United States

Issuing Office:
Florida District Office

United States


 

  

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Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-17-04
December 22, 2016
Cappie Hose, Majority Partner/President
Florida Key West, Inc.
3150 County Line Rd Ste 1
Lakeland, FL 33811
 
Dear Mr. Hose:
 
The Food and Drug Administration conducted an inspection of your firm located at located at 3150 County Road, Suite 1, Lakeland, FL 33811, on August 31, 2016 through September 12, 2016. During that inspection, we found significant deviations from the Juice Hazard Analysis and Critical Control Point (HACCP) regulation [21 Code of Federal Regulations (CFR) Part 120]. In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Accordingly, your lemon juice and lime juice products 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, FDA’s Juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.
 
Your significant deviations are as follows: 
  • You must develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice that you process, and you must have and implement a written HACCP plan whenever that hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.7(a) and 120.8(a). However, your firm does not have written hazard analyses or written HACCP plan or plans for your reconstituted 100% lemon juice and lime juice products to control microorganisms.
Furthermore, you must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). The "pertinent microorganism" is defined as "the most resistant microorganism of public health significance that is likely to occur in the juice."
 
We acknowledge receipt of your response received by the FDA Florida District Office on October 12, 2016, and review of that response revealed that it is not adequate. Specifically, your response did not include any written hazard analyses or HACCP plans specific to your juice products and juice processing operation. Although your response included HACCP documentation from your foreign lemon and lime juice concentrate suppliers, your firm meets the definition of a processor and is subject to the juice HACCP regulation.  Consequently, you cannot rely on the HACCP documentations from your suppliers to satisfy the HACCP requirements specific to your processing operation. In addition, the juice HACCP regulation, 21 CFR 120.24(c), requires the 5-log reduction and final product packaging to be performed within a single production facility operating under good manufacturing practices. Therefore, you cannot use the 5-log reduction applied to the juice concentrates by your suppliers to satisfy the 5-log reduction requirement for juices produced at your processing facility.
 
The above is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that all of your products are in compliance with applicable statues and regulations enforced by the FDA. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
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 re-inspection-related costs. A re-inspection 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. 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 noncompliance materially related to a food safety requirement of the Act, Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long-term corrective actions, such as evidence that you are working with a process authority, an updated hazard analysis and a validated HACCP plan. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
 
Your response should be sent to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Mr. Morris at 407-475-4741.
 
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District
 
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