Inspections, Compliance, Enforcement, and Criminal Investigations
Conservas y Congelados YAESTA, S.A. 2/17/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
FEB 17, 2011
VIA EXPRESS MAIL
Mr. Francisco Menendez, Owner and General Manager
Conservas y Congelados YA ESTA, S.A.
5 Calle 12-59 Zona 2 De Mixco
Colonia La Escuadrilla
Guatemala City, Guatemala
Dear Mr. Menéndez:
We inspected your processing facility, Conservas y Congelados YA ESTA, S.A., located at 5 Calle 12-59 Zona 2 De Mixco, Colonia La Escuadrilla, Guatemala City, Guatemala on October 25-29, 2010. At the conclusion of that inspection, our investigator issued a FDA Form 483, a form listing the observations of concern noted during the inspection. We found that you are manufacturing 100% juice pulp products subject to the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). We found that you have serious violations of the requirements of the HACCP regulation. In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice products 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). Accordingly, your frozen fruit pulp products (such as mamey, mango, and nance) are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
The significant deviations are as follows:
1. For your frozen fruit pulp products, you must perform a 5-log reduction, in the pertinent microorganism(s), to comply with 21 CFR 120.24(a). This 5-log reduction and final product packaging must be accomplished in your facility through treatments applied directly to the juice to comply with 21 CFR 120.24(b) and (c). However, your firm fails to perform a 5-log reduction in frozen fruit pulp for Salmonella.
2. You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 120.8(b)(2). However, your firm’s HACCP plan for frozen mamey pulp does not list the critical control point of pasteurization for controlling the food safety hazard of pathogens.
3. You must have a written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, you do not have a HACCP plan for nance pulp and mango pulp exported to the USA to control the hazard of pathogens.
4. You must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records of the proper labeling, storage, use of toxic compounds.
We have reviewed your firm’s response dated November 10, 2010, in which you responded to the FDA-483 Observations that was issued at the completion of the inspection. We find the response inadequate in that it does not provide evidence that the required corrections have been made and that your firm is in compliance with 21 CFR 120.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, or other useful information that would assist us in evaluating your corrections. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, subjecting future shipments of your firm’s frozen fruit pulp offered for import into the United States to Detention Without Physical Examination (DWPE).
Please send your reply to the U. S. Food and Drug Administration, Attention: Doriliz De Leon, Compliance Officer, Office of Compliance, Division of Enforcement, Product Adulteration Branch (HFS-606), 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 Mrs. De Leon at (301) 436-2772 or via email at Doriliz.DeLeon@fda.hhs.gov.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
And Applied Nutrition