Golden Gate Soy Food, Inc. 11/28/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
via United Parcel Service
Delivery Signature Required
November 28, 2012
Nian Xia Xie, President
Golden Gate Soy Food, Inc.
1265 Griffith Street
San Francisco, California 94124
Dear Mrs. Xie:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 1265 Griffith Street, San Francisco, California between September 12 and 21, 2012. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the tofu and soy based food products produced in your facility 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 been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov
Your significant violations are as follows:
Processes and controls:
1. All reasonable precautions must be taken to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. However:
a. September 12, 2012, our investigators observed an employee using unsanitary water from the cold water bath for adding into in-process tofu. Our investigators observed plastic milk crates, routinely stored on the floor of your facility, had been placed in the cold water bath for cooling product; and previously used processing equipment, such as a strainer and tofu press sheet, were dipped in this cold water bath for rinsing. Also, they observed non-food particles such as metal fragments, dirt, and small pieces of plastic in the water.
b. September 12, 2012, our investigators observed an employee acquiring dirty water from a filthy 55 gallon drum using a dirty bucket to add into packages of finished ready-to-eat tofu. White and brown debris were observed floating in the water; black and brown stains were found on the interior wall of the drum; and the bucket was spotted with black residues.
2. Equipment and utensils and finished food containers must be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary, as required by 21 CFR 110.80(b)(1). However:
a. September 13, 2012, our investigators observed the cold water bath had only been partially drained with remaining dirt, small pieces of plastic, and other debris such as metal fragments, after your firm’s sanitation operations.
b. Our investigators observed caked tofu residues on the insides of the large metal vat used to hold tofu, leftover soybean particles in the soybean grinder, and residual soy whey in the whey separator. These observations were made after cleaning and sanitation had been performed.
c. Our investigators observed a white bucket, with black spotted residues, was being used to transfer water into finished food.
3. Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). However, on September 12, 2012, our investigators observed aluminum trays used for holding ready-to-eat product were stored upright on the floor leaning against a concrete-based pillar, coated with yellow stains and tofu residue, while being rinsed with a water hose. The trays were then stacked on top of a rusty paint-chipped cart prior to being used to hold ready-to-eat tofu. Some of the trays were intermittently soaked in a 55 gallon drum of cloudy water before being used to hold ready-to-eat tofu.
4. 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, as required by 21 CFR 110.10(b).
a. One method for maintaining cleanliness is to wash hands thoroughly and sanitize, as necessary, 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 (21 CFR 110.10(b)(3)). However, on September 12 and 13, 2012, our investigators did not observe any production employees wash their hands. In fact, our investigators noted the only hand washing sink near the production area of your facility was filled with cardboard and was not in use.
b. Another method for maintaining cleanliness is to maintain gloves, if they are used in food handling, in an intact, clean, and sanitary condition (21 CFR 110.10(b)(5)).
i. On September 12 and 13, 2012, our investigators observed employees with gloved hands routinely pick up water hoses which were stored on the floor and/or in pooled water on the floor, and then proceed to directly handle ready-to-eat tofu products without washing, sanitizing, or changing gloves.
ii. On September 12, 2012, our investigators observed an employee with gloved hands perform various tasks touching dirty surfaces (the handle of a rusted paint-chipped cart, a brown-stained refrigerator door handle, and broom to sweep the floor) and then proceeded to directly touch ready-to-eat tofu for packaging without first changing, washing, or sanitizing his gloves.
iii. On September 13, 2012, our investigators observed a different employee cough into his gloved hands and then immediately touched ready-to-eat tofu. This same employee was observed packaging ready-to-eat tofu by placing twist-ties in his mouth, transferring the tofu by hand into the plastic bag, and then using the twist-tie from his mouth to seal the plastic bags of finished product.
c. A third method for maintaining cleanliness is to confine the following activities to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco (21 CFR 110.10(b)(8)).
i. On September 13, 2012, our investigators observed an employee wash his personal food storage containers and eating utensils in the cold water bath which was later used as a direct water source for processing tofu. The same employee was also observed to dip these personal items in the plastic 55 gallon drum of water used to soak aluminum trays before the trays were used to hold ready-to-eat tofu.
ii. On September 12, 2012, our investigators observed a personal coffee cup stored on top of a stack of aluminum trays which were later used in processing ready-to-eat tofu.
Sanitary facilities and control:
5. Plumbing shall be of adequate size and design and adequately installed and maintained, as required by 21 CFR 110.37(b).
a. One method of maintaining plumbing is to avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition to comply with 21 CFR 110.37(b)(3). However, on September 13, 2012, our investigators observed a water hose stored on the ground in your production room floor.
b. Another method of maintaining plumbing is 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 to comply with 21 CFR 110.37(b)(4).
i. On September 12, 2012, our investigators observed pooling of soymilk on the production room tiled floor. The production room drain was observed to be clogged with debris.
ii. On September 13, 2012, our investigators observed a stream of soap suds from the laundry machine which lacks a drain. All wastewater from the washing machine was observed to drain directly onto the production room floor.
6. No pests shall be allowed in any area of a food plant. You must take effective measure to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests to meet the requirements of 21 CFR 110.35(c). However, on September 12, 2012, our investigators observed at least 20 live flies flying approximately 3-5 feet above and within exposed ready-to-eat tofu and soymilk products in the manufacturing areas during production.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the current status of your corrective actions and the specific steps that you have taken to correct the noted violations. You should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state the time within which you will complete the remaining corrections.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the attention:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Barbara J. Cassens
San Francisco District Director