Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
November 22, 2013
RETURN RECEIPT REQUESTED
Ref. – KAN 2014-04
Mr. James P. Gantz, President/Owner
Vendors Unlimited Corporation
10554 Route 52N
Dubuque, IA 52001
Dear: Mr. Gantz:
The Food and Drug Administration inspected your food processing facility, located at 10554 Route 52N Dubuque, IA 52001 from October 29-November 8, 2013. We found that you have serious violations of the Current Good Manufacturing Procedures (CGMP) for Human Food, Title 21, Code of Federal Regulations, Part 110. These violations cause the food products manufactured 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 were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s homepage, www.fda.gov.
Specifically, our inspection of your facility revealed the following violations:
1. Failure to adequately use sanitizing agents as required by 21 CFR 110.35(d)(5). During our inspection, investigators documented that you are not using a sanitizing agent appropriately. The concentration was checked and found to be (b)(4) ppm when the sanitizer directs use at (b)(4)-(b)(4) ppm.
2. Failure to conform to hygienic practices when handling food or directly contacting food surfaces as required by 21 CFR 110.10(b). During our inspection, investigators observed the following deviations:
- Employees handling components used in the production of ready-to-eat sandwiches such as non-sanitized black bread trays and Styrofoam trays after performing cleaning activities with bare hands and without washing their hands.
- Employees using a gloved hand to pick up a knife from the floor and then continue to make ready to eat sandwiches without changing gloves after contacting the floor.
- Employees handling food contact surfaces (Styrofoam trays) after contacting the floor without cleaning their hands.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Your response should be sent to Patrick L. Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 80th Street, Lenexa, Kansas 66214-3340.
Dr. Ann Adams
Acting District Director
Kansas City District Office