Inspections, Compliance, Enforcement, and Criminal Investigations
Comercializadora Segura de Cartago S.S.R. S.A 3/26/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD|
MARCH 26, 2013
VIA EXPRESS DELIVERY
Mr. Saul D. Segura, President
Comercializadora Segura de Cartago S.S.R. S.A.
50 metros al este del Pali de Cot
50M Este Y 75M
Oreamuno, Cartago, 30705
Reference No.: 393759
Dear Mr. Segura:
The U.S. Food and Drug Administration (FDA) inspected your produce farm and packing house located at Comercializadora Segura de Cartago S.S.R. S.A., 50 metros al este del Pali de Cot , Oreamuno, Cartago, Costa Rica on November 6-7, 2012. During that inspection, our investigators observed significant objectionable conditions and practices which cause the carrots 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 they have been prepared, packed, or held under insanitary conditions whereby they 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.
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 documentation of corrections from your firm.
We observed the following insanitary conditions and practices:
- There were no toilets or hand washing facilities in the field for the (b)(4) employees that were harvesting produce. Adequate toilets and hand-washing facilities are necessary for the sanitary manual harvest of produce.
- Employees washed their hands using a hose because there was no running water in the employees’ restroom at the packing house. The restroom was not easily accessible because vehicles were parked in front of it. The toilet and sink in the restroom were visibly dirty and there was no toilet paper. Hand-washing with a hose is inadequate because the employees have to handle the hose which is not sanitized. Further there were no towels for drying. Your employees directly handle the carrots so it is essential that they properly wash and sanitize their hands.
- According to your description, your employees drag plastic crates containing carrots across the floor and place them on the table to be packed and weighed. There are no controls in place, such as foot baths or special footwear, to prevent transfer of microbes from outside or regions such as the toilet onto the packing facility floor. The bottoms of the crates are open and the crates are not washed or sanitized prior to placing them on the table.
We also observed that you are using (b)(4) as a pesticide. There is no tolerance established for (b)(4) in the United States. A product that bears or contains a pesticide chemical that is unsafe within the meaning of section 408(a) of the Act [21 U.S.C. § 346 (a)] is adulterated under Section 402(a)(2)(B) of the Act [21 U.S.C. § 342(a)(4)]. A pesticide is considered unsafe within the meaning of section 408(a) if there is no tolerance established for the pesticide. Product treated with (b)(4) cannot be offered for sale in the United States.
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 contain documentation that would assist us in evaluating your corrections, such as detailed descriptions and photographs of corrective actions. 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.
Office of Compliance
Center for Food Safety
and Applied Nutrition