Inspections, Compliance, Enforcement, and Criminal Investigations
Roselife, LLC 02-Sep-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
September 2. 2008
Mr. Rodney K. Dean, Owner
dba Rosewood Products
738 Airport Boulevard, Suite 6
Ann Arbor, Michigan 48108-1674
On June 3-6, 2008, the Food and Drug Administration (FDA) conducted an inspection of your soymilk and ready-to-eat (RTE) tofu manufacturing facility located at 738 Airport Boulevard, Suite 6, Ann Arbor, Michigan. We found that you have significant deviations from the current Good Manufacturing Practice (cGMP) regulations for food. manufacturers, 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 rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
Specifically, our inspection of your facility revealed the following sanitation violations:
1. In order to comply with section 21 CFR 110.40(a), all plant equipment shall be so designed and of such material and workmanship as to be adequately clearable and shall be properly maintained. Food contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. On June 4, 2008, our investigators observed the following:
- A non-food-grade aquatic-type submersible pump with electrical cord was completely immersed in raw soymilk in a plastic container at the soybean grinding station. The same pump was observed being used to transfer and pump the soy milk to the Vibratory Fine Grinding machine for further processing.
The inspectors observed that this type of non-food-grade pump is not easily cleanable and, therefore, cannot be properly maintained to preclude the adulteration of food with contaminants.
- The same type of non-food-pump with electrical cord was completely immersed in a plastic container office water and was being used to transfer the ice water directly into finished product trays of tofu.
2. In order to comply with 21 CFR 110.80(b)(2), all food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. On June 3rd, our investigators observed the following:
- An employee in the tofu production area was dumping scoops of yellow-colored liquid from a large cooking kettle directly into the floor drain within close proximity (approximately three feet) of the area where tofu was being processed. Splatter from the liquid hitting the floor was observed coming into direct contact with the cheesecloth that lined a rack containing uncovered in-process Fresh Organic Tofu. The cheesecloth was then observed being draped over the tofu, coming into direct contact with the product.
- An employee in the processing area was using a pressurized water hose to rinse the workroom floor within close proximity of four uncovered 35-gallon plastic containers of soaking soy beans that were later used to manufacture "FIRM TOFU"in 5 lb. value packs with a sell by date of "Jul 03, 08." Water splatter from the floor was observed moving up and around the openings of the containers.
- An employee was placing wire mesh screens previously used to hold finished tofu blocks during slicing directly into a chlorine sanitizer without washing and rinsing off adhering pieces of tofu. Such residue should be removed before utensils and equipment are sanitized and reused.
3. In order to comply with 21 CFR 110.20(b)(4), plant buildings and structures shall be constructed in such a manner that floors, walls, and ceilings maybe adequately cleaned and kept clean and kept in good repair, and that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4).
Our investigators observed that during production of RTE tofu, the tofu production room floor was in disrepair, with deep cracks, crevices, and depressions preventing proper water drainage. The condition of your flooring allows a buildup of contamination that can be tracked throughout the plant by foot traffic and can eventually find its way onto food contact surfaces.
4. In order to comply with 21 CFR 110.80, all operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source.
On June 3, 2008, our investigators observed an ungloved employee in the tofu production area picking up a hose from the floor arid using it to fill finished product tofu containers with ice water.
5. In order to comply with 21 CFR 110.10(b)(3), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, including washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable organisms) in an adequate hand-washing facility at any time when the hands may have become soiled or contaminated; as required by 21 CFR 110.10(b)(3).
On June 3, 2008, our investigators observed that the ungloved employee who had picked up a hose from the floor of he tofu production area then went back to hand-packing finished product tofu into containers without washing or sanitizing his hands.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. It is your responsibility to ensure that your processing plant operates in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Judith A. Jankowski, Detroit District Office, 300 River Place, Suite 5900, Detroit. Michigan 48207. if you have any questions regarding any issues in this letter, please contact Judith A. Jankowski at 313-393-8125.
Joann M. Givens
Detroit District Office