Visoy Food, Inc. 1/20/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
January 19, 2012 W/L 16-12
Mr. Eddie C. Hwang, President
Visoy Food, Inc.
111 W Elmyra St.
Los Angeles, CA, 90012-1818
Dear Mr. Hwang:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Visoy Food, Inc, located at 111 W Elmyra St, Los Angeles, CA, 90012, on October 21 – November 4, 2011. You are manufacturing tofu products including, pressed tofu, tofu strips, baked tofu, and fried tofu. You are also manufacturing soy based beverages, and Chinese style teas.
The inspection revealed serious violations of Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110), the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food. Accordingly, your tofu products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (Act) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Additionally, during the inspection, our investigator collected labels for your Baked Soy Bean Cake and Fried Soy Bean Cake products. Our review of the labels for these products revealed that these products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
You may find the Act, FDA regulations, and FDA guidance documents, including the Food Labeling Guide, through links in FDA's website at www.fda.gov
The significant violations documented during the inspection include the following deviations from CCGMPs:
- You must maintain equipment, utensils and finished food containers in acceptable condition through appropriate cleaning and sanitizing as necessary in order to comply with 21 CFR 110.80 (b). However we observed the bottom of crates that had been on the floor in contact beverage bottles that were ready to fill.
- You must handle work in process in a manner that protects against cross contamination in order to comply with 21 CFR 110.35 (b)(5). However our investigator observed liquid from the bottom of a bucket drip onto in process soy tofu. The bucket had been sitting directly on the floor. The investigator also observed water leaking from a leaking hose bib over an unsanitized hose onto soaking beans.
- You must clean and sanitize utensils and equipment in a manner that protects against the contamination of food, food contact surfaces or food-packaging materials to comply with 21 CFR 110.35(a). However, we observed an employee washing food processing utensils directly on the production floor. We also observed pressure spray used for cleaning equipment splash onto the floor and then to in process tofu. These practices are likely to contaminate your product with human pathogens that may be on the floor.
- You must locate and operate fans in a manner that minimizes the potential for contamination of food, food-packaging materials and food-contact surfaces to comply with 21 CFR 110.20(6). However, a fan that had dust and black residue was blowing directly onto tofu in the production room.
- You must take effective measures to exclude pests from the processing areas, however we observed flies too numerous to count in the processing room and crawling on the finished baked soy bean cake, processing utensils and the vats.
Further, your Baked Soy Bean Cake and Fried Soy Bean Cake products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the labels for these products fail to provide nutrition facts information in accordance with 21 CFR 101.9.
o The serving size declaration for this product is not based on the reference amount customarily consumed (RACC) established for this specific type of product, as required by 21 CFR 101.12(b). Specifically, your Fried Soy Bean Cake declares a serving size of “2 oz. (57g),” however the RACC established for bean cake (tofu) is 85 grams [21 CFR 101.12(b), Table 2]. Therefore, a serving size for bean cake must be based on the RACC of 85 grams. We calculate that 3 oz. of your product would weigh approximately 85 grams, which appears to be closer to the appropriate RACC for this product.
o The product label does not declare the number of grams of trans fat in a serving, as required by 21 CFR 101.9(c)(2)(ii).
o The serving size declaration for this product, "3 oz. (85g)," is not expressed in an appropriate common household measure or unit. Under 21 CFR 101.9(b)(5)(iv), for products that come in discrete units (e.g., piece, slice, cracker, bar), a description of the individual unit must be used in expressing serving size in household measures. For example, a sample serving size statement for bean cake (tofu) products that come in discrete pieces is "_ piece(s) (_ g)" [21 CFR 101.12(b)].
o The product label does not declare the number of grams of trans fat in a serving, as required by [21 CFR 101.9(c)(2)(ii).
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective action. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
Director Compliance Branch
Los Angeles District
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
Alonza E. Cruse
Los Angeles District
California Department of Public Health
Food and Drug Branch
Ingeborg Small, Branch Chief
1500 Capitol Avenue, MS-7602
P.O. box 997435
Sacramento, CA 95899-7435