Inspections, Compliance, Enforcement, and Criminal Investigations
Edenic Soy & Tofu, Inc 7/26/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
July 26, 2011
Mr. Chauncey E. Cloquitt
Edenic Soy & Tofu, Inc.
1735 West Greenleaf Avenue
Chicago, Illinois 60626
Dear Mr. Cloquitt:
The U.S. Food and Drug Administration (FDA) inspected your firm, located at 1735 West Greenleaf Avenue in Chicago, IL 60626, between February 1, 2011 and February 8, 2011. The inspection revealed that you have serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause your tofu and soy drink products 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)] because your food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, our investigators collected and reviewed samples of the labels of your Edenic Firm Tofu and Edenic Soy Drink products. Based on our review of your labels, we have concluded that these products are misbranded within the meaning of Section 403 of the Act [21 U.S.C.§ 343]. You may find the Act and its implementing regulations through links on FDA's home page at http://www.fda.gov.
- Your plumbing must be of adequate size and design and adequately installed and maintained, to comply with 21 CFR 110.37(b). However, your plumbing is not adequate as evidenced by the following observations.
- There were dead legs connected to the plumbing that supplies water to your ice machine, manufacturing sink, and toilet facility. Dead legs can foster the growth of bacteria, which may include human pathogens, inside the pipes that supply water to your facility. Water from the manufacturing sink is used as an ingredient for your tofu and is used for cooling tofu during manufacturing (21 CFR 110.37(b)(3)).
- There was no air gap or backflow prevention device in the plumbing that supplies water to the cooling tank that sits in front of the sink. Without backflow prevention, contaminated water may be going into your cooling tank (21 CFR 110.37(b)(5)).
- The plumbing on your tofu cooling sink, ice machine, and mop sink drains directly onto the production room floor, as opposed to draining into a sewer or other waste water disposal system. This practice results in a wet production room floor, which can foster the growth and spread of human pathogens, especially Listeria monocytogenes (21 CFR 110.37(b)(2)).
- There was standing water and organic material on the floor of the production room where employees were walking, demonstrating a lack of adequate floor drainage (21 CFR 110.37(b)(4)).
- Your employees must wash their hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3). However, on 2/1/2011 an employee touched the production room floor while cleaning up organic matter from under the grinding machine. The same employee then dipped his hand in the cooling sink water that was holding tofu for cooling without washing and sanitizing his hands between tasks.
- You must maintain gloves, if they are used in food handling, in an intact, clean, and sanitary condition, to comply with 21 CFR 110.10(b)(5). However, an employee opened the walk-in cooler, moved a wooden pallet, and opened a box of spice mix while wearing green rubber gloves. The same employee then dumped the spice mix into a mixing bowl, added water and immersed his gloved hand into the bowl to mix spices into the water without cleansing and sanitizing the gloves between tasks. The mixture was then poured directly into a batch of ready to eat tofu mix. In addition, another employee picked up a block of tofu with his gloves after rinsing them with water from the nozzle of a hose that had been on the production room floor.
- You must take effective measures to protect against the inclusion of metal in food, to comply with 21 CFR 110.80(b)(8). However, your firm used a frayed and torn metal screen during the tofu pressing operation, where it came in direct contact with tofu liquid and tofu This practice may lead to contamination of your product with metal fragments.
- You must construct, handle, and maintain equipment, containers and utensils used to convey, hold, and store raw material, work-in-process, rework, or food in a manner that protects against contamination, to comply with 21 CFR 110.80(b)(7). However, white buckets that are used to hold finished bulk tofu were stored upside down in direct contact with a dirty wooden shelf and direct food contact storage bins were stored upside down in direct contact with the production room floor.
- All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food, to comply with 21 CFR 110.35(d). However your food-contact surfaces were not adequately cleaned as evidenced by:
- A black mold-like substance on the packaging machine used to convey tofu.
- A chain caked with organic matter and a black mold like substance that was touching in-process tofu.
- Your equipment and utensils must be of such material and workmanship as to be adequately cleanable and must be properly maintained, to comply with 21 CFR 110.40(a). However, you used a wooden stirring utensil that was shredded. Wood, and particularly rough wood, cannot be adequately cleaned because bacteria tend to collect in any rough spot or porous surface. Moreover, use of a shredded stirring utensil risks contaminating food with foreign material. In addition, the interior of the “funnel” piece of equipment that dispenses soy drink has a rough welded surface which cannot be adequately cleaned.
- You must properly store equipment 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, to comply with 21 CFR 110.20(a)(1). However, there were vines growing along the east outer wall that could constitute a harborage for pests.
- Your employees must wear hair nets, beard covers, and hair restraints, where appropriate, in an effective manner, to comply with 21 CFR 110.10(b)(6). However, on 2/1/2011, while manufacturing ready to eat tofu, three employees were not wearing hair nets or any other form of hair restraint. In addition, one employee with facial hair was not wearing a beard cover.
- Yourplant must be constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair, to comply with 21 CFR 110.20(b)(4). However, the wall of your production room where tofu and soy drinks are manufactured had extensive shredded paint within a foot from where tofu products are manufactured. In addition, your production room floor was cracked exposing the concrete aggregate, which is a porous surface that can serve as a reservoir for pathogens.
1. Your Edenic Firm Tofu is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. Specifically, Imported Japanese Natural Nigari is used as a [b4] for your Edenic Firm Tofu and this additive is listed as an ingredient on the finished product label as “Imported Japanese Natural Nigari.” The common or usual name of this additive is magnesium chloride and thus should be listed on the finished product label as such. In addition, our investigator was informed that when [b4] is unavailable, you use [b4] as a [b4] instead. Manufacturers who are unable to adhere to a constant pattern of [b4] in the food may use "or," "and/or," or "contains one or more of the following" to list the [b4] that may not be present in the product (21 CFR 101.4(b)(19)).
2. Your Edenic Soy Drink is misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the product fails to bear a label listing an accurate statement of the net quantity of the contents in terms of weight, measure, or numerical count, to comply with 21 CFR 101.105(a).
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with all applicable laws and regulations administered by FDA. The specific violations noted in this letter and the Inspectional Observations, Form FDA-483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing process. You should investigate and determine the cause of these violations, and take prompt action to correct these violations. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and/or injunction.
In addition, we have the following comment:
You may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see [http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingnutrition/ucm053857.htm] for information on filing for an annual exemption. The application may be submitted online at: https://info1.cfsan.fda.gov/nle/client/login.cfm.
A hard copy of the Small Business Nutrition Labeling Exemption instructions and a blank application form are also enclosed.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225 or firstname.lastname@example.org.
Scott J. MacIntire