|Subject:||CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated|
|Issuer:||Los Angeles District Office|
|Issued:||Aug. 8, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Los Angeles District, Pacific Region
RETURN RECEIPT REQUESTED
August 8, 2008
Mr. Long H. Lai
4849 University Avenue
San Diego, CA 92105
Dear Mr. Lai:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 4849 University Avenue, San Diego, CA 92105 on May 29-30, 2008. The inspection revealed insanitary conditions and serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110-Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (GMP). These conditions cause the food products produced in your facility, including soy beverages, soybean curd, and "soy bean pudding" 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 held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act and the GMP regulation for foods at www.fda.gov .
Your significant violations were as follows:
1. Failure to hold and store foods that can support the rapid growth of microorganisms at a temperature and in a manner that prevents the food from becoming adulterated, in order to comply with 21 CFR 110.80(b)(3). Your perishable sweetened soy milk, unsweetened soy milk, fried tofu, fresh tofu, and fresh tofu pudding were not kept refrigerated as specified on the product labels. These products were observed to be transported in an unrefrigerated van and were allowed to be sold unrefrigerated in ambient temperature for extended periods of time.
2. Failure to conduct all food manufacturing under such conditions and controls as are necessary to minimize the potential for the contamination of food, to comply with 110.80(b)(2). We observed the following practice that allowed your products to become contaminated: on 5/29/08, an employee was seen causing water used to clean the dirty processing room floor and the side of what appeared to be a refuse container to splash directly into a vat of in-process tofu curd, onto the food contact surfaces of the tofu press table and forms, and onto foam trays used to pack tofu.
3. Failure to exclude pests from all areas of your food plant, in order to comply with 21 CFR 110.35(c). Specifically, we observed the following conditions during our inspection:
a) A domestic cat was observed in your processing area and was housed within that area at all times.
b) Two guard dogs are allowed to roam in your facility each evening.
c) Rodent excreta and urine stains were observed to be collected in sagging ceiling tiles directly above the processing room
d) An exterior door was open during processing. There were at least eight blowfly-like insects and sewer fly-like insects too numerous to count in the production area while in-process tofu was exposed.
4. Failure to ensure that plant equipment and utensils are of such material and workmanship as to be adequately cleanable, to comply with 21 CFR 110.40(a). Specifically, we observed plastic horticulture racks used to press and hold tofu, which were of a material that appeared not to be intended for food use. These racks were designed with grooves and holes that make them not easily cleanable.
5. Failure to ensure that 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 by preventing eating and drinking in areas where food may be exposed, to comply with 21 CFR 110.10(b)(8). Specifically, we observed several containers of partially consumed beverages in the processing area during processing, and two employees were observed drinking beverages in the processing area.
6. Failure to have adequate hand-washing facilities for use by employees, to comply with 21 CFR 110.37(e). Specifically, your hand-washing facilities lacked soap and hand-drying towels or a drying device (21 CFR 110.37(e)(2) and (3)).
7. Failure to ensure that 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 by washing hands thoroughly and sanitizing, if 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, to comply with 21 CFR 110.10(b)(3). Specifically observed was an employee handling ready-to-eat fresh tofu with bare hands while packing the tofu into one-pound retail-labeled packages. The employee was observed failing to wash her hands prior to handling the tofu on multiple occasions when hand-washing was required, including after handling a hose that had been on the wet processing room floor, after handling a plastic crate that had been on the wet processing room floor, and after at least three absences from the tofu-packing station.
8. Failure to maintain toilet facilities in good repair, in order to comply with 21 CFR 110.37(d)(2). Specifically, your sole processing area toilet was observed to be leaking water from the base when flushed.
During the inspection, we obtained copies of your product labeling. Review of these labels revealed that several of your products are misbranded under section 403 of the Act [21 U.S.C. 343].
Your LIFESOY® Natural Soymilk Unsweetened (1/2 gallon), LIFESOY® Natural Soymilk Sweetened (1/2 gallon), LIFESOY Fresh Tofu (16 oz.), and LIFESOY® Fried Tofu (16 oz.) are misbranded under section 403(q) of the Act [21 U.S.C. 343(q)] because their labels fail to declare trans fat in their Nutrition Facts panels [21 CFR 101.9(c)(2)(ii)]. Regulations requiring the declaration of trans fat went into effect on January 1, 2006 [see 21 CFR 101.9(c)(2)(ii); 68 FR 41433]. You should review all of your product labels to ensure they comply with these regulations. For additional information on trans fat labeling, go to http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat .
Your LIFESOY® Fried Tofu (16 oz.) and LIFESOY® Fresh Tofu (16 oz.) are misbranded under section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that the label fails to declare the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
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 laws 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 (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
We have several additional comments regarding your labeling. Your LIFESOY® Natural Soymilk Unsweetened (1/2 gallon) and LIFESOY® Natural Soymilk Sweetened (1/2 gallon) products use the term "milk" as part of their common or usual name. Milk is a standardized food defined as the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows [21 CFR 131.110]. Therefore, we do not consider "soy milk" to be an appropriate common or usual name because it does not contain "milk." We do consider "soy drink" or "soy beverage," however, as acceptable common or usual names for such products.
Your LIFESOY® Fried Tofu (16 oz.) product label fails to formatting requirements specified in 21 CFR 101.9. For example:
• Your product label fails to declare the serving size by the equivalent metric quantity in parentheses [21 CFR 101.9(b)(7)].
• Your product label fails to round the values for certain nutrients as specified by 21 CFR 101.9(c). For example, your sodium levels should be expressed to the nearest 5 milligram increment [21 CFR 101.9(c)(4)], and your iron percentage should be expressed to the nearest 5-percent increment [21 CFR 101.9(c)(8)(iii)].
• Your product label fails to separate the nutrient information for vitamins and minerals from information on other nutrients by a bar [21 CFR 101.9(d)(8)]; and
• Your product label fails to round the number of servings per container to the nearest whole serving, e.g., "about 5 servings" [21 CFR 101.9(b)(8)(i)].
The amount of calories declared on the label of your LIFESOY® Natural Soymilk Sweetened appears to be incorrect, based on the other values provided in the Nutrition Facts label. Your sweetened soy beverage and your unsweetened soy beverage labels both declare 90 calories per serving; however, your sweetened product label declares 17g of Total Carbohydrates, compared to 4g of Total Carbohydrates in your unsweetened product (both products declare 4g Total Fat and 9g Protein). One gram of carbohydrates contains about four calories [21 CFR 101.9(d)(10)]. Therefore, because the sweetened product appears to contain 13 more grams of carbohydrates than the unsweetened product, the sweetened soy beverage should contain about 50 calories more than the unsweetened product.
Further, the amount of sugar listed on the label of your LIFESOY® Natural Soymilk Sweetened appears to be incorrect. According to the ingredient statement, sugar is the only ingredient that is present in the sweetened product but not the unsweetened product. Therefore, sugar is the only ingredient that could contribute to the higher level of carbohydrates in the sweetened product than in the unsweetened product, and the 13 additional grams of carbohydrates that appear to be present in the sweetened product should be attributed to the addition of sugar. However, while the sweetened product label lists 17g of carbohydrates (compared to 4g on the unsweetened product label), the sweetened product. label lists only 4g of sugar (compared to 0 g on the unsweetened product label).
The net quantity of contents statements on LIFESOY® Natural Soymilk Sweetened (1/2 gallon) and LIFESOY Fried Tofu (16 oz) are of insufficient type size. While we are not able to determine the required type size in the absence of sample containers, the type size that appears on these product labels is less than 1/8 inch. The area of the submitted labels is between 5 and 25 square inches. A 1/8 inch type size is the minimum type size for a net quantity of contents statement, based on the area of the submitted labels [21 CFR 101.105(i)(2)]
Finally, we note that some of the information on the labels of your LIFESOY® Natural Soymilk Sweetened, LIFESOY® Natural Soymilk Unsweetened, and LIFESOY® Fried Tofu is provided in English and in an additional language. Under 21 CFR 101.15(c), all information required by or under the authority of the Act to appear on the label shall appear thereon in English, and if any representation is made on the label in a foreign language, all the required information must also appear on the label in the foreign language.
Your written reply should be addressed to:
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions regarding this letter, please contact Mr. Robert B. McNab, Compliance Officer at 949-608-4409.
Alonza E. Cruse
Cc: California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413