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  5. American Spice Trading Company Inc. - 11/13/2014
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WARNING LETTER

American Spice Trading Company Inc.


Recipient:
American Spice Trading Company Inc.


United States

Issuing Office:
Florida District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
                Fax: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-15-06
November 13, 2014
 
Mr. Robert A. Urra, President
American Spice Trading Company, Inc.
Post Office Box 420531
Miami, FL 33142
 
Physical Address:
5561 NW 36th Avenue
Miami, FL 33142
 
Dear Mr. Urra:
 
On May 21, 2014 – June 23, 2014, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located 5561 NW 36th Avenue, Miami, Florida where you manufacture acidified foods and juice products. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Parts 120).
 
Accordingly, we have determined that your Pampas brand Lemon Juice products are 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)], in that they have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find this Act and the corresponding regulations through links on FDA’s home page at www.fda.gov.
 
During our inspection, we observed the following significant violations:
 
Juice HACCP
 
1.    You must include in your HACCP plan, control measures that will consistently, at a minimum, effect a 5-log reduction of the pertinent microorganisms, for a period at least as long as the shelf life of the product when stored under normal or moderate abuse conditions, to comply with 21 CFR 120.24(a). Specifically,
 
You have not identified pathogens in your HACCP plan as a hazard.
 
You do not have in your HACCP plan a validated control measure to achieve a 5-log reduction.
 
Your firm receives juice concentrate, processes this juice into your Pampas Lemon Juice product and distributes this product without ensuring a 5-log reduction process control measure is applied and consistent. You have not asserted or provide a validation study to show that Critical Control Points1 (pH control) achieves a 5-log reduction of the pertinent pathogen. The Critical Control Points you provided is inadequate because the “hold time” was not identified as a critical limit. 
 
You must validate your process with identification of all critical factors if you want to use pH as a Critical Control Point to achieve a 5-log pathogen reduction. You must identify a “hold time” component as a critical limit within your validated process.
 
For additional information you should reference the preamble to the final juice HACCP rule at the following link: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072557.htm
 
2.    Your HACCP plan must list the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a) and (b)(1). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your firm’s HACCP plan for your Pampas brand Lemon Juice product does not list the pertinent microbiological hazards that are specifically related to your juice products, such as Salmonella, Escherichia coli O157:H7, and Listeria Monocytogenes. 
 
Once you have identified these hazards, you must also include control measures in your HACCP plan for the monitoring of these hazards. For information to control these food safety hazards, you may refer to the following link or The Juice HACCP Controls Guidance, First Edition:
 
 
3.    You have included corrective actions in your HACCP plan. Accordingly your described corrective actions must be appropriate to comply with 21 CFR 120.8(b)(5). However, your corrective action plan for “Liquid Blends – Acidic Juices”, specifically for “lemon juice from concentrate” at Critical Control Point-1 (pH) , is not adequate to comply with 21 CFR 120.10(a)(2). Your HACCP plan includes corrective action procedures that do not address identifying and correcting the causes of the deviation. Additionally, the specific corrective action for the product, i.e. addition of citric acid, is not appropriate for “lemon juice from concentrate” since added citric acid is not an ingredient permitted by the standard of identity for lemon juice from concentrate in accordance with 21 CFR 146.114. The acidity of lemon juice from concentrate may only be adjusted by addition of lemon juice or lemon juice concentrate as stated in 21 CFR 146.114 (a)(2).
 
4.    You must validate your HACCP plan for your lemon juice product, as required by 21 CFR 120.11(b). Processors shall validate that their HACCP plan is adequate to control food hazards that are reasonably likely to occur; this validation shall occur at least once within 12 months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way. Specifically, you failed to validate and maintain documentation of data validation for the critical factors with your “Liquid Blends – Acidic Juices” HACCP plan.
 
5.    You must have and implement a sanitation standard operating procedure that addresses sanitation conditions and practices before, during, and after processing, as required by 21 CFR 120.6(a), and you must adequately monitor conditions and practices during processing with sufficient frequency to ensure conformance with those conditions, as well as the current good manufacturing practice requirements in 21 CFR Part 110, as required by 21 CFR 120.6(b). However, your firm did not monitor safety of the water, prevent cross contamination from insanitary objects to food, and exclude pests with sufficient frequency as evidenced by the following observations at your facility on June 05, 2014 and June 13, 2014:
 
a)    The waste drain pipe on the three compartment equipment wash sink in the dry blend room was leaking onto the floor. This waste drain is also directly plumbed to the drain and lacks an adequate air gap to prevent cross contamination.
 
b)    The roll-up loading bay door in the liquid blend room exhibited a large gap, approximately one inch in height along the length of the bottom of the door allowing for the inadequate exclusion of pests from your facility.
 
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
 
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) working 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 or your scheduled process has been filed with the FDA. 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 written response should be sent to Erica M. Katherine, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Ms. Katherine at (407) 475-4731.
 
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District