Inspections, Compliance, Enforcement, and Criminal Investigations
Country Bakery, LLC 8/5/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Denver District Office|
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
August 5, 2013
Via UPS Overnight
Mr. Scott A. Brown
Country Bakery, LLC
823 Lane 14 1/2
Lovell, WY 82431
Ref. No: DEN-13-19-WL (DR)
Dear Mr. Brown:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 823 Lane 14 1/2 June 19-24, 2013. The inspection found that you have serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR) Part 110 (21 CFR 110). These conditions cause the bakery/granola products produced 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 your bakery/granola products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act and the CGMP food regulations through links on the FDA’s homepage at http://www.fda.gov. A copy of the FDA-483, Inspectional Observations, issued to you at the close of our inspection, is attached with this letter.
The specific CGMP violations observed during the inspection include, but are not limited to, the following:
1. Buildings and Facilities: Sanitary Operations/Sanitary Facilities and Controls (21 CFR 110.35 and 110.37, Subpart B)
a. You failed to take effective measures to exclude pests from the processing and raw material storage areas in your facility as required by 21 CFR 110.35(c). Specifically, we identified significant evidence of rodent and insect activity in and around your facility, including mice, cockroaches, wasps, moths, ants, and spider-like pests.
b. You failed to use sanitizing agents in a safe and adequate manner as required by 21 CFR 110.35(d)(5). Specifically, sanitizing water in your bakery’s two compartment sink tested at significantly higher than 200 ppm chlorine. This is a higher percentage of sanitizer than is recommended by the sanitizer manufacturer for use in a food production facility. When excessive amounts of sanitizer are used, the sanitizing agent can become incorporated into foods and cause the sanitizer to be considered an unapproved dietary ingredient.
c. You failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). For example, food contact surfaces such as the block table covered with Formica and maple table are damaged and chipping. In addition, the drainage pipe under the 3-compartment sink is repaired using duct tape, which is not an easily-cleanable material, and the right faucet handle of the 2-compartment sink is broken and has been replaced with a wrench.
d. You failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food packaging materials as required by 21 CFR 110.35(a). Specifically, you have not incorporated a cleaning step in your cleaning/sanitizing operations before sanitizing of food processing surfaces.
e. Your toilet facilities lack self-closing doors as required by 21 CFR 110.37(d)(3).
2. General Provisions: Personnel (21 CFR 110.10, Subpart A)
a. You failed to take necessary precautions to protect against contamination of food, food contact surfaces, and food packaging systems with microorganisms and foreign substances as required by 21 CFR 110.10. Specifically, on numerous occasions, employees were observed touching raw dough and finished bakery products after pushing up their soiled sleeves, wiping their face, and/or touching dirty equipment without washing their hands.
b. Personnel responsible for identifying sanitation failures and food contamination lack a background of education and experience to provide a needed level of competency as required by 21 CFR 110.10(c). The lack of a sanitary production environment demonstrates a failure to receive or provide appropriate training in proper food handling techniques and food-protection principles.
3. Buildings and Facilities: Plants and Grounds (21 CFR 110.20, Subpart B)
a. You failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, gaps were noted in window, door, and roof/wall joint structures, allowing potential for entry of pests into your production facility. A gap in the siding and roof junction, where a dead bird and nesting was identified, has allowed moisture to damage the ceiling and create a hole where contaminants can enter and adulterate the bakery products packaged on the table directly below the damaged ceiling and hole.
b. You failed to properly store equipment, remove litter and waste, and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures as required by 21 CFR 110.20(a)(1).
c. You failed to operate fans and other air blowing equipment in a manner that minimizes the potential for contaminating food, food-contact surfaces, and food-packaging materials as required by 21 CFR 110.20(b)(6). Fans covered with dust and insect webbing were observed blowing directly on finished bakery products, specifically bread, during our inspection.
d. Your plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and in good repair as required by 110.20(b)(4). For example, the floor in your walk-in freezer consists of raw, unsealed wood; the floor in the storage room outside the walk-in freezer is damaged and has product stored on unsealed wood; and the cement floor in the bakery room is not sealed. Unsealed flooring allows moisture to penetrate and floors to get damaged creating pits and cracks where bacteria can collect.
4. Production and Process Controls: Processes and Controls (21 CFR 110.80, Subpart D)
a. You failed to maintain equipment, containers and utensils used to convey food in a manner that protects against contamination as required by 110.80(b)(7). Specifically, our inspection found the canvas conveyor, the water transfer hose, and the bread slicer conveyor belt to be in, and/or stored in, an unsanitary condition.
b. You failed to store raw materials in a manner that protects against contamination as required by 21 CFR 110.80(a)(1). For example, raw ingredients, including chocolate chips, molasses, corn syrup, and finished, packaged granola, were stored directly on the floor in the walk-in storage room. The floor in the storage room is damaged and not covered in material that is easily cleanable or adequate to prevent moisture transfer.
The above violations are not intended to be an all-inclusive statement of violations that exist in your facility. You have been cited for many of these items several times before, but you have taken no corrective action in response to those citations. You are responsible for investigating and determining the causes of the violations identified above and for preventing the recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law, the Act, and its implementing regulations. You should take prompt action to correct violations cited in this letter and establish procedures to ensure such violations do not recur. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Address your reply to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.
LaTonya M. Mitchell
Denver District Director