Native American Enterprises, LLC 8/9/13
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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
August 9, 2013
RETURN RECEIPT REQUESTED
Ref. – KAN 2013-13
Mr. William N. McGreevy, Owner
Native American Enterprises, LLC
230 N West St
Wichita, KS 67203
Dear: Mr. McGreevy:
The Food and Drug Administration inspected your food processing facility, located at 230 N West St, Wichita, KS 67203 from June 24-July 19, 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 handle equipment, containers and utensils used to convey food in a manner that protects against contamination as required by 21 CFR 110.80(b)(7). During our inspection, investigators observed a control panel used as a storage shelf for a product scoop to transfer ready to eat refried beans from totes into the bulk storage hopper was not properly cleaned after being contaminated by condensation from the ceiling caused by hot water rinsing.
2. Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). During our inspection, investigators observed walls, floors and coving to be in poor repair in both the cook and pack off rooms, containing loose fiberglass panels, holes, loose caulking and cracks that prevent thorough cleaning and sanitizing.
We acknowledge receipt of your written response, dated July 29, 2013, to the FDA-483 issued at the close of the inspection on July 19, 2013. We reviewed your response and found it inadequate in that you did not provide detail about the proposed corrective actions or a holistic approach to corrective actions. We will verify adequacy of these corrective actions during the next inspection.
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.
In addition, an environmental sample, INV 803602, collected during the inspection found Listeria monocytogenes and Listeria welshimeri from various locations in the processing area, which may indicate insanitary conditions in your facility.
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.
John W. Thorsky
Kansas City District Office