Inspections, Compliance, Enforcement, and Criminal Investigations
Vend Serve, Inc. 28-Apr-05
Department of Health and Human Services
Public Health Service
New Orleans District
April 28, 2005
WARNING LETTER NO. 2005-NOL-2
Mr. Nicholas D. Cheriogotis
Vend Serve, Inc.
1750 Kinsey Road
Dothan, Alabama 36303-5864
Dear Mr. Cheriogotis:
On February 16, 17, 24, and 25, 2005, United States Food and Drug Administration (FDA) investigators inspected your smoked tuna dip manufacturing facility, located at 1750 Kinsey Road, Dothan, Alabama. We found serious deviations from the Seafood Hazard Analysis Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan to comply with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), Title 21 United States Code, Section 342(a)(4). You may find the Act and the Seafood HACCP regulations through links in FDA's Internet home page at http://www.fda.gov. Accordingly, your ready-to-eat, smoked tuna dip is adulterated, since it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
The deviations are as follows:
You failed to conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur and have a written HACCP plan to control any food safety hazards reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for ready-to-eat, smoked tuna dip to control the food safety hazard of pathogen growth and toxin formation. This was previously brought to your attention in our letter to you dated March 29, 2004.
You failed to maintain sanitation control records documenting, at minimum, monitoring and corrections, to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the following items: (1) safety of water used in processing; (2) condition and cleanliness of food contact surfaces; (3) prevention of cross-contamination from insanitary objects to food, food packaging materials, and other food contact surfaces; (4) maintenance of hand-washing, hand-sanitizing, and toilet facilities; (5) protection of food, food packaging material, and food contact surfaces from adulteration with contaminants; (6) proper labeling, storage, and use of toxic compounds; (7) control of employee health conditions which could result in microbiological contamination; and, (8) exclusion of pests from the facility required for the processing of ready-to-eat, smoked tuna dip. This was previously brought to your attention in our letter to you dated March 29, 2004.
You failed to adequately monitor the protection of food, food packaging material, and food contact surfaces from adulteration with condensate and other biological or physical contaminants, to comply with 21 CFR 123.11(b)(5). In particular, there are holes and cracks in the walls in two of the dry goods storage areas where cookies, snack cakes, donuts, chips, carbonated beverages, and water are stored . In addition, unused equipment, which could harbor pests, are scattered throughout the dry goods area. This was previously brought to your attention in our letter to you dated March 29, 2004.
We may take further action if you do not promptly correct these violations. For instance, we may seize your product and/or enjoin your firm from operating. You made a verbal commitment to cease manufacturing the smoked tuna dip.
Please respond in writing within 15 working days from your receipt of this letter outlining the specific steps you are taking to correct these deviations, or remain committed to halt manufacturing smoked tuna dip. Should you continue to manufacture the smoked tuna dip, please include in your response any documentation, such as your revised HACCP plan, copies of sanitation monitoring records, copies of temperature monitoring records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not intend to be an all-inclusive list of the deviations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, Seafood HACCP regulations, and the Current Good Manufacturing Practice regulations (21 CFR 110). You also have a direct responsibility to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, 6600 Plaza Drive, Suite 400, New Orleans, Louisiana 70127. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 253-4519
Patricia K. Schafer
Acting District Director
New Orleans District