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Tofu Yu, LLC MARCS-CMS 513233 —

Tofu Yu, LLC

United States

Issuing Office:
San Francisco District Office

United States


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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone (510) 337-6700 


Our Reference: CMS 513233
December 22, 2016
Kevin E. Strong, Co-Owner/President
Tofu Yu, LLC
2618 8th Street
Berkeley, CA 94710-2514
Dear Mr. Strong:
Between October 11 and 25, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 2618 8th Street, Berkeley, California. During our inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110).  Accordingly, we have determined that the ready-to-eat tofu and tofu products, including tofu veggie wraps, produced in your facility are 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 its implementing regulations through links in FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1.    Equipment and utensils and finished food containers must be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary, to meet the requirements of 110.80(b)(1). However, our investigators observed on October 11 and/or October 19, 2016:
a.  Your firm’s pitcher used to transfer coagulant for tofu production was discolored with dried, yellow and brown residues. 
b.  Your plastic tofu shape-maker was discolored with dark yellow residues.
c.  Your tofu press plate contained dark yellow dried residues which appeared to be discolored dried tofu matter.
d.  Your rice tortilla making equipment was visibly dirty with dried residues at the end of the roller line.
e.  Your wooden cutting board used to cut raw vegetables for ready-to-eat tortilla wraps was visibly dirty and discolored.
2.    All reasonable precautions must be taken to ensure that production procedures do not contribute contamination from any source, to meet the requirements of 21 CFR 110.80. However, on October 11 and 12, 2016, our investigators observed uncovered tofu products on shelves were stored immediately adjacent to a path of condensate dripping from the cooler fan unit located in the walk in cooler used to store tofu.
3.    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 October 11, 2016, our investigators observed live flying insects (approximately 30) in the tofu manufacturing area during processing. The flies were perched on the wall adjacent to the tofu press equipment and on a green hose suspended between the walls above the tofu processing equipment. Additionally, our investigator observed flying insects coming into contact with tofu processing equipment such as on the interior surface of a soybean soaking barrel containing soybeans soaking in process and on the conveyer belt area. Similar observations of flying pests were made during our previous inspections of your facility.
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, to meet the requirements of 21 CFR 110.10(b).  One method for maintaining cleanliness is for employees 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 contaminate (21 CFR 110.10(b)(3)). However, on October 11, 2016, our investigator observed one employee, who was making rice tortillas for tortilla wraps, touch his face and nose with his bare hand and then directly touch the tortilla wrap without washing his hands before resuming food handling work. Similar observations of poor employee hygienic practices have been made during our previous inspections of your facility. 
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or with respect to your products. You are responsible for ensuring that your facility and your products are in compliance with the Act and applicable regulations. We may take further action if you do not promptly correct the violation noted in this letter. For instance, we may seize your product(s) and/or enjoin your firm from operating.   
As discussed with you during the inspection, our investigator noted a few issues regarding one of your food product’s labeling, specifically “Spicy Tortilla Wrap”. We remind you that you must ensure all of your food products are labeled in compliance with our laws and regulations. FDA’s food labeling requirements are found in 21 CFR Part 101.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 FFD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
You should respond in writing within fifteen (15) working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again.  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.
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
Please reference CMS # 513233 in your response.
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer, at 510-337-6793.
Kathleen M. Lewis, J.D.
San Francisco District Director

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