Inspections, Compliance, Enforcement, and Criminal Investigations
Agroindustrias Mora S.A. 2/5/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD
February 5, 2013
VIA EXPRESS DELIVERY
Mr. Randal Mora Segura
Agroindustrias Mora S.A.
Santa Rosa Oreamuno,
50M Este Y 75M,
Norte De La Cruz Roja,
Cartago, Costa Rica
Reference No.: 391820
Dear Mr. Segura:
The U.S. Food and Drug Administration (FDA) inspected your produce harvesting and packing house located at Santa Rosa Oreamuno, 50M Este Y 75M, Norte De La Cruz Roja, Cartago, Costa Rica on October 19-20, 2012. During that inspection, our investigators observed a number of objectionable conditions and practices which cause the foods at your facility 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 they have been prepared, packed, or held under insanitary conditions whereby the produce 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 in FDA's home page at www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. Upon request from our office via e-mail, on December 17, 2012 you submitted several images of some work that was being done in your packinghouse; however, no descriptions or details of what observations these images related to was provided. You informed us that the work was in progress; however, no estimation on a date of completion was provided. We have assessed your response and find it inadequate to alleviate our concerns with the deviations that were observed during the inspection.
We observed the following insanitary conditions and practices:
1. Water from the hog pen flowed downhill in a drainage ditch through the middle of the farm following a downpour into a ditch that bordered rows of young carrots. Animals are known zoonotic disease reservoirs for human pathogens; therefore, run-off containing excreta from the hogs may contaminate the produce.
2. There were no sanitary facilities available for workers. The closest facilities were over 500 meters away from the field. FDA recommends that you provide personnel with adequate, readily accessible toilet facilities, including toilet facilities readily accessible to growing areas during harvesting activities.
3. Wastewater leaked from the septic tank and flowed downhill along rows of carrots. The septic tank contained waste from the house toilet and is likely to contain human pathogens which could have contaminated the produce it came in contact with.
4. You dumped carrots into dirty untreated water.
We also observed that you are using carbendazim as a pesticide, which causes products treated with these pesticides to be adulterated under Section 342(a)(2)(B) of the Act because they bear a pesticide which is unsafe within the meaning of 346a(a) in that there is no tolerance established for the pesticide. Product treated with carbendazim should not be offered for sale in the United States.
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 further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. All images should be accompanied by descriptions and explanations. If you cannot complete all corrections within fifteen (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 them 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 any questions regarding any issue in this letter, you may contact Ms. D’lima at (240) 402-2033 or via email at Carol.Dlima@fda.hhs.gov.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition