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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Green Hope LLC dba Rosewood

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313·393·8100
FAX: 313-393-8139 

 

 
WARNING LETTER
2011-DET-08
 
May 6, 2011   
 
VIA UPS
 
 
Mr. Phil G. Ye, Owner
Green Hope, LLC
dba Rosewood
738 Airport Blvd Suite 6
Ann Arbor, MI 48108-1674
 
 
Dear Mr. Ye:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 738 Airport Blvd Suite 6, Ann Arbor, MI on February 28 through March 16, 2011. 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 in 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 become contaminated with filth or rendered injurious to health. You may find the Act and the CGMP regulation through links on FDA's home page at www.fda.gov.
 
The following violations were observed during the inspection:

1.  You failed to ensure that all persons working in direct contact with food conform to hygienic practices while on duty, by taking necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with micro-organisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin, as required by 21 CFR 110.10(b)(9). Specifically:

  • On 3/1/2011, during the processing of ready-to-eat tofu, an employee used his mouth to siphon liquid through a plastic hose from a kettle containing approximately (b)(4) gallons of ready to eat tofu after the coagulation process had occurred. The inside surface of that same hose contained a heavy accumulation of adhering white colored residue. The likelihood of microbial cross contamination from possible backflow from the employee's mouth to finished product tofu was further increased by a lack of designation as to which end of the hose was to come in contact with the employee's mouth and which end was to be submerged into the product.
  • On at least three occasions, two employees used their mouths and plastic hoses to siphon water from a 35-gallon container, which was being used as a weight on top of tofu racks during the pressing operation. Water from that same container was overflowing and leaking down onto the uncovered racks of ready to-eat tofu below.
  • On 2/28/2011, three employees lowered racks of unwrapped ready-to-eat tofu down into an ice water bath in a tank, with their bare, uncovered arms exposed. The employees' bare uncovered arms then came in direct contact with the water being used to cool un-wrapped tofu.

2. You failed to conduct food manufacturing under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically:

  • An employee was observed using a white plastic scoop to remove foam from the top of post steamed soy milk, then lowering the scoop to within 2 feet of the production room floor and then rinsing it with pressurized water which forced water spray droplets bouncing from the floor to come into direct contact with the scoop. That same scoop was then immediately re-used to remove more foam from the kettle with no cleaning or sanitizing between uses. After the employee was instructed by your firm's management to cease this action, another employee was observed rinsing a strainer in the same manner and then using it in direct contact with un-pressed ready-to-eat tofu curds.
  • An employee used a pressurized water hose to spray the outside of a kettle containing approximately (b)(4) gallons of unfiltered soy milk (pre-steaming) and water spray droplets were observed impacting the workroom floor and then aerosolizing near the opening of the same kettle. 
  • An employee used a pressurized water hose to spray a strainer used to scoop raw soybeans into a hopper approximately two feet above the workroom floor and about five feet from uncovered filtered soy milk. Soybean waste and excess foam residue was observed on the work room floor and the aerosolized water spray droplets impacting the floor were observed in direct contact with the strainer, which was later used to scoop raw soy beans with no cleaning or sanitizing before use.
  • Water spray from a pressurized water hose being used by an employee was impacting the work room floor and then aerosolizing back onto the food contact surface of a previously cleaned pressing table used for manufacturing ready-to eat tofu. According to firm management, this same table was not cleaned and sanitized prior to the next tofu production.

3. You failed to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food by washing their hands thoroughly (and sanitizing 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, as required by 21 CFR 110.10(b)(3). Specifically:
 

  • On 2/28/2011, 3/1/2011, and 3/2/2011 an employee touched heavily soiled mechanical power switches, which were covered with thick black colored residue, and then immediately placed his hands into cooling steamed soymilk to remove the film formed on top, known as tofu skin. The employee did not wash and sanitize his hands prior to touching the soy milk and tofu skins. These switches are routinely used during production to control the product transport pump and a power strip. 
  • On 2/28/2011, 3/1/2011 , and 3/2/2011, employees handled a pressurized water hose spray nozzle/handle which was heavily soiled with black colored residue and rust and then immediately handled ready-to-eat tofu with no hand washing and sanitizing between jobs.
  • On 3/1/2011, an employee used a floor squeegee that was touching the North wall to press down or compact soybean waste into a garbage can and then his hands came into direct contact with ready-to-eat tofu curds while he was wrapping them with towels during the pressing process. The North wall contained scattered black spots that appeared to be mold. The employee did not wash and sanitize his hands between jobs.
4. You failed to ensure that all persons working in direct contact with food, food contact surfaces, and food-packaging materials conform to hygienic practices
while on duty, by wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food packaging
materials, as required by 21 CFR 110.10(b)(1). Specifically:
  • An employee's work apron came into direct contact with the waste container, while the employee was pressing down waste inside the container, and then it
    came into contact with the pressing racks and cheese cloths used for pressing ready-to-eat tofu.

5. You failed to conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR Part 110.35(a). Specifically:

  • The plastic racks/trays used for storing unwrapped ready-to-eat tofu in thecooler were not cleaned on 3/1/2011 during cleanup operations; rather the racks were just dipped into water containing a chlorine solution, which contained floating pieces of tofu. These same racks were later filled with ready-to-eat tofu, stacked on top of each other in the cooler, and water was draining from the racks on top onto the racks containing tofu below.
  • The cream colored racks for pressing ready-to-eat tofu were used on 2/28/2011, 3/1/2011, and 3/2/2011 without being washed or sanitized.
  • The tofu slicer was not washed or sanitized during your firm's clean-up operations on 3/2/2011.

6. You failed to ensure that all plant equipment and utensils are designed and of such material and workmanship as to be adequately cleanable and to ensure that the design, construction and use of equipment precludes the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants, as required by 21 CFR 110.40(a). Specifically:

  • The tofu press, located in the southwest comer of the processing room, had rust and flaking paint on its exterior surface, which was located approximately 5 inches above uncovered ready-to-eat tofu.
  • The cream colored racks used for holding and pressing ready-to-eat tofu had a reddish brown stain and rough flaking edges with an adhering white/yellowish colored residue.
  • The connecting rod of the tofu slicer was oxidized with green residue, which came into direct contact with ready-to-eat tofu during the slicing operation.

7. You failed to ensure that all persons working in direct contact with food, food contact substances, and food-packaging materials conform to hygienic practices while on duty, by wearing hair nets and appropriate hair restraints in an effective manner, as required by 21 CFR Part 110.10(b)(6). Specifically:

  • On 2/28/2011 and on 3/2/2011, an employee was observed shoveling ice to cool unwrapped tofu and reaching over uncovered ready-to-eat tofu during packaging with approximately 6 inches of hair hanging out of her hairnet.

8. You failed to properly hold and store toxic cleaning compounds, sanitizing agents, and pesticide chemicals in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR Part 110.35(b)(2). Specifically:

  • On 2/28/2011, 3/1/2 and on 3/2/2011, a cart holding a bottle of hydrogen peroxide, and cleansing powder was located approximately I foot away from pound bags of magnesium chloride used as a coagulant during the processing 0 ready-to-eat tofu.

9. You failed to provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor, as required by 21 CFR Part 110.37(b)(4). Specifically:

  • On 2/28/2011, 3/1/2011, and 3/2/2011 during the processing of ready-to-eat tofu, there was not less than 1/16 inch of standing water on the work room floor surface.

The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with applicable statutes and regulations. 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 and/or injunction.

Please respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Steven B. Barber, Director, Compliance Branch, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have questions regarding any issue in this letter, please contact Mr. Barber, at (313) 393-8100, extension 8110.

Sincerely,
/S/

Glenn T. Bass

Acting District Director
Detroit District Office