DEPARTMENT OF HEALTH & HUMAN SERVICES
March 8, 2012
VIA OVERNIGHT DELIVERY
Mr. Christophe Fontaine, General Director
Katope Brazil, Ltda
Rod. BR 122, Lote 02
Quadra C. Loteamento Jardim Boa
Esperanca, Petrolina, Brazil
CEP 56320700, Caixa Postal: 521
Reference No. 276637
Dear Mr. Fontaine:
The U.S. Food and Drug Administration (FDA) inspected your firm at Katope Brazil, Ltda, Rodovia BR 122, No 02, Lot. Jardim Boa Esperanca, Petrolina, Brazil on September 19-21, 2011. The inspection was conducted to assess the compliance of your table grapes with the Federal Food, Drug, and Cosmetic Act (the Act). During that inspection, we documented conditions and practices that render your table grapes adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You may find the Act through links in FDA’s home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigator provided you with a form FDA 483 which presents the investigator’s observations. Based on the FDA’s observations, your significant violations were as follows:
Water used in the packing house and the employee bathrooms is filtered but otherwise untreated water obtained from the Sao Francisco River in Brazil. Water in the packing house is routinely used by employees at hand washing stations as well as to wash food contact surfaces (gray and white plastic containers that come into direct contact with grapes). Employees used their bare hands to pack your table grapes. Untreated surface water is a common source of pathogenic strains of Escherichia coli, Salmonella spp., Vibrio cholerae, Shigella spp., Cryptosporidium parvum, Giardia lamblia, Cyclospora cayetanensis, Toxiplasma gondii, and the Norwalk and Hepatitis A viruses. Even small amounts of contamination with some of these organisms can result in foodborne illness. The sand filtration you are using is not adequate to eliminate pathogens form water. We recommend you to take a proactive role in minimizing the microbial hazards, specifically those related to water that comes in direct contact with your table grapes, water used on food contact surfaces and water for human use.
Several employees wiped their faces with their bare hands and then touched the inside of the plastic bags prior to placing bunches of fresh grapes into the bags. The employees did not wash their hands after touching their faces. This practice could contaminate your grapes.
These observations are significant because table grapes are commonly consumed without any intervening treatment to control pathogens.
We acknowledge that you responded via email on October 7, 2011. However, your response is inadequate because you did not document your corrections.
Please respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations and documentation such as a food safety plan, photos, records of training, monitoring logs or results of a third party audit addressing cleaning and sanitation of food contact, or other useful information that would assist us in evaluating your corrections.
Please send your reply to the Food and Drug Administration, Attention: Maria Lau, CFSAN 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 this letter, you may contact Maria Lau by phone at (240) 402-2271 or via email at Maria.Lau@fda.hhs.gov.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition