Mr. David T. Millstein
Dear Mr. Millstein:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located 710 E. 22nd
Street, Ste C, Lawrence, Kansas, from May 20 through May 21, and July 1, 2014. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause the food products produced and stored at your facility, including Hickory Smoked, Firm (type), and Garlic Herb Tofu to be adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act) in that they have also been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. You can find the Act and its implementing regulations at www.fda.gov
1. You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c) and evidenced by the following:
a. What appeared to be a live roach was found on the leg of a food processing table inside the finished product packaging area.
b. What appeared to be a live roach was found under a pallet of dried soybeans in the warehouse area of the plant.
c. An apparent gnaw hole was found on a bag of Nigari (lot# 110415), an ingredient used in the production of your tofu.
d. Apparent rodent droppings were found around bags of dried soybeans in the warehouse area. The warehouse is directly adjacent to the production area.
2) The facility and procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment as required by 21 CFR 110.35(d)(5). Specifically, on May 20, 2014, after producing tofu your procedure for cleaning and sanitizing food contact equipment by using hot water only does not provide adequate cleaning and sanitizing. The inside of the smoker used to smoke tofu contained accumulated debris. The corners of a metal food cart found in the packaging area contained debris.
3) Failure to take apart equipment as necessary to ensure thorough cleaning as required by 21 CFR 110.80(b)(1), Specifically, You do not fully dissemble all food contact equipment after processing and before the start of manufacture. The barrels with the screens used to extract the soy milk from the soy pulp had accumulated food debris inside parts of the screen.
4) Failure to have smoothly bonded or well-maintained seams on food contact surfaces, to minimize accumulation of food particles and the opportunity for growth of microorganisms as required by 21 CFR 110.40(b). Specifically, on May 20, 2014, during the manufacture of hickory smoked, firm (type), and garlic herb tofu several food contact tables and a food cart were found to have unsanitary welds. Also in the production area inside the hopper and the holding vats for the soybeans prior to the cooking kettle had rough welds.
5) Failure 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). Specifically, during the inspection conducted on May 20, 2014, the following harborage areas were found inside and outside your facility:
a. Several bags of soybean meal were stored outside on the loading dock area. One bag was split open and apparent rodent droppings were found in and around the spilled food product.
b. The area around the loading/receiving dock and door is overgrown and weeds are not trimmed around the front and side of the facility. Unused equipment is also stored outside on the loading/receiving dock
6) Instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms are not accurate as required by 21 CFR 110.40(f). Specifically, on May 20, 2014, during the inspection of your facility, the temperature of cooling tofu was taken and the thermometer used by your employee read (b)(4) degrees F. The temperature of the Tofu was also taken with an FDA calibrated thermometer and the temperature recorded was 135 degrees F.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
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 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.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and prevent their recurrence. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to the Food and Drug Administration, Attention: Danial S Hutchison. If you have questions regarding any issues in this letter, please contact Mr. Hutchison at (913) 495-5154 or Danial.Hutchison@fda.hhs.gov
Cheryl A. Bigham