Inspections, Compliance, Enforcement, and Criminal Investigations
Branson Baking Co 3/17/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
March 17, 2014
CMS # 421843
Trevor K. Clifton, Owner
Branson Baking Co.
1612 Point Royal Dr.
Branson, MO 65616
Dear Mr. Clifton:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2496 Hwy T. Branson, MO 65616, from January 31, 2014 to February 11, 2014. The inspection found significant deviations from FDA’s regulations for Current Good Manufacturing Practice (CGMP) in the manufacturing, packing, or holding of human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110) These deviations 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 may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov.
Specifically, our inspection of your facility revealed the following deviations from the CGMP regulations:
1. Your firm failed to appropriate clean and sanitize equipment as required by 21 CFR 110.80(b)(1). Our investigator observed apparent food residue on the following utensils and pieces of equipment used in the production area prior to production:
a. Heating trays used for icing
b. A knife used for cutting yeast dough products
c. A spatula/flat edged cutter used for yeast dough products
d. The main dough mixer
e. Racks used to hold finished product
f. The cake donut batter hopper swivel arm
Additionally, our investigator observed your cleaning procedure for utensils did not contain a sanitizing step and that washing of some utensils was not effective as food residue remained.
This deviation was also observed by the state of Missouri Department of Health and Senior Services on two previous inspections (May 23, 2008 and January 31, 2011)
2. Your facility is not constructed in a manner to allow the floors to be adequately cleaned and kept clean as required by 21 CFR 110.20(b)(4). On January 31, 2014, the investigator observed grease, apparent food residue, and dirt buildup on the concrete floors throughout the production area.
This deviation was also observed by the state of Missouri Department of Health and Senior Services in its most recent inspection (September 19, 2013).
3. Food contact surfaces used for the manufacturing of apple fritters (bear claws), and a variety of other yeast dough products have wide cracks which allow for the accumulation of food particles and other foreign matter. This is a deviation from 21 CFR 110.40(b).
4. Your firm has not designated an individual or individuals to supervise overall sanitation in the plant as required by 21 CFR 110.80.
5. Outer garments worn by employees are not suitable in that they do not protect food and food contact surfaces from being contaminated as required by 21 CFR 110.10(b)(1). Specifically, our investigator observed an apron which was soiled with caked-on dough being used in production touching food contact surfaces such as utensils and worn while leaning over baked, ready-to-eat product.
6. Employees failed to adequately wash their hands prior to starting work manufacturing food as required by 21 CFR 110.10(b)(3). Our investigator observed employees washing their hands and using a soiled rag to dry their hands immediately prior to handling food product.
7. Your firm is not taking appropriate precautions to prevent contamination of the food you are manufacturing as required by 21 CFR 110.10(b)(9). On January 31, 2014, our investigator observed prior to production a dustpan with debris inside on a work table which serves as a food contact surfaces for yeast dough products. Next to the dustpan were food ingredients.
In addition to the CGMP deviations, our records indicate that your firm is not registered with FDA as a food facility as required by section 415 of the Act [21 U.S.C. § 350d]. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, [21 U.S.C. § 331(dd)].
We request that you, an individual authorized by you, register the facility with FDA. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, you may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. You can request the paper forms and submit completed forms by fax to 301-436-2804 or by mail to:
U.S. Food and Drug Administration
Food Facility Registration (HFS-681)
5100 Paint Branch Pkwy
College Park, MD 20740.
You also may request the paper forms by phone at 1-800-216-7331 or 301-575-0156. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your facility. It is your responsibility to ensure that your firm complies with the Act and its implementing regulations. 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, injunction, and/or prosecution.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
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 sent to U.S. Food and Drug Administration, Mr. Matthew R. Sleeter, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Compliance Officer Sleeter can be reached at (913) 495-5151 or email Matthew.Sleeter@fda.hhs.gov
David L. Miser
Acting Director, Kansas City District