July 15, 2013
RETURN RECEIPT REQUESTED
Mr. Steve Ellenberger, Owner/CEO
The Bagel Works Café, Inc.
1523 South 45th Street
Kansas City, Kansas 66106
Dear Mr. Ellenberger:
The Kansas Department of Agriculture (KDA), under contract on the behalf of the United States Food and Drug Administration (FDA), inspected your manufacturing facility located at 1523 South 45th
Street, Kansas City, Kansas 66106 on June 12, 2013. The inspector found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods 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 been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page www.fda.gov
The June inspection was a follow-up to previous KDA inspections of your facility between May 15-21, 2013. The May 2013 KDA inspections found significant CGMP violations, including: failure to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests; failure to clean food contact surfaces as frequently as necessary; failure to protect food from contamination; failure to maintain adequate plumbing to prevent contamination; failure to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from becoming adulterated. We acknowledge that in response to the KDA findings, you voluntarily closed your manufacturing operation on May 15, 2013, and destroyed approximately (b)(4) lbs. of dough, bakery ingredients, ready-to-eat bread loaves and bagels that were prepared, packed or held under insanitary conditions. In addition, we acknowledge that you worked with KDA to implement corrections to the observed GMP deficiencies from the May 15, 2013 inspection, and that KDA authorized commencement of your manufacturing operations on May 21, 2013.
KDA’s inspection of your facility on June 12, 2013 revealed the following repeated CGMP violations from the May 2013 inspections:
- Your firm failed to take effective measures to exclude pests from processing areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Inspectors observed evidence of pest infestation by live cockroaches. Adult (with apparent egg sack) and juvenile cockroaches were observed on the floor in the catering/three compartment sink area, and on the floor behind proofers near storage shelves.
- Your firm failed to protect food from contamination, as required by 21 CFR 110.20(b)(2). Inspectors observed fans used to cool product with dust build-up in the north walk-in cooler. Uncovered dough is stored on racks in this cooler.
- Your firm failed to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Inspectors observed the following:
- Broken gaskets on the walk-in cooler and proofer doors.
- Two dead cockroaches between the table top and leg of the wooden prep table in the production area.
- Your firm failed to maintain equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary, as required by 21 CFR 110.80(b)(1). Inspectors observed food containers, bread pans, bread sheet trays, food scoops, and utensils with significant food build-up on direct food contact surfaces.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products or injunction.
We request that you notify this office in writing, within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you can not complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 re-inspection-related costs.
Your response should be directed to: Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions, please do not hesitate to call CO Hensley at (913) 495-5183 or send her an email at Jessica.email@example.com
John W. Thorsky
Kansas City District Office
Kansas Department of Agriculture
Division of Food Safety and Lodging
109 S.W. 9th St.
Topeka, KS 6661