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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Asociacion de Pequenos Agricultores Comalapenses de Producto 3/26/13

  

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

Public Health Service
Food and Drug Administration
 College Park, MD 

MARCH 26, 2013

WARNING LETTER
 
 
 
VIA EXPRESS DELIVERY
 
 
Mr. Marvin O. Icu, General Manager
Asociacion de Pequenos Agricultores Comalapenses de Productos No Tradicionales
0 Ave. Camino a Guadalupe 4-21 Zona
San Juan Comalapa, Chimaltenango
Guatemala
 
Reference No.: 393761
 
Dear Mr. Icu:
 
The U.S. Food and Drug Administration (FDA) inspected your produce farm and packing house located at the above address on December 11-13, 2012. During that inspection, our investigators observed significant objectionable conditions and practices which cause the produce that you grow and pack to be 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 it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA's home page at www.fda.gov.
 
At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, that listed the deviations found at your firm. At the end of the inspection, you promised to make corrections; however, to date we have not received any response with corrections from your firm. 
 
We observed the following insanitary condition and practice:
 
Your firm has three pits that collect sewage and processing wastewater from the bathroom and packing houses. The sewage pits are constructed of dirt and are unsealed and, therefore, are exposed to insects and other animals that may spread pathogens from the pits onto your fields. Further, these sewage pits are shallow (ranging between 5 and 32 feet deep) and are located uphill and directly adjacent to the blackberry and pea growing fields (ranging between 4 to 30 feet from the field).  Because of the location and construction of the sewage pits, they have the potential to seep and overflow onto your fields when it rains.  
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation that would assist us in evaluating your corrections, such as a detailed description of the corrections you have implemented along with photographs to document these 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.
 
If you do not respond or if we find your response inadequate, we may take further action.  For instance, we may take action to refuse admission of your imported produce under Section 801(a) of the Act [21 U.S.C. § 381(a)], including placing it on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts which can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
 
This letter may not list all the violations at your firm. You are responsible for ensuring that your firm operates in compliance with the Act and FDA regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
 
Please send your reply to the U. S. Food and Drug Administration, Attention:  Carol D’lima, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607) 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have questions regarding this letter, you may contact Carol D’lima at (240) 402-2033 or via email at Carol.Dlima@fda.hhs.gov.
                                                                                    
Sincerely,
/S/ 
Roberta Wagner
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition