| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda. CA 94502-7070 Telephone: 510/337-6700 |
Department of Health and Human ServicesWarning Letter
Via UPS and Facsimile
Our Reference: 2911750
September 2, 2010
James Franklin Stephens
President & CEO
Quong Hop & Co.
40 Airport Blvd.
South San Francisco, CA 94080
Dear Mr. Stephens:
From April 27 through May 4, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 40 Airport Blvd., South San Francisco, California. Based on our findings, we have determined that your products are 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 been rendered injurious to health. Further, your "Raquel's Hummus & Dip Spicy Hummus" product is misbranded within the meaning of sections 403(i) and (q) of the Act [21 U.S.C. § 343(i) and (q)] in that its label fails to bear the comnmon or usual name of each ingredient and the nutrition facts information does not comport with the content and format requirements in FDA regulations. You can find the Act and FDA regulations through links in FDA's home page at http://www.fda.gov.
During the inspection, FDA investigators collected a variety of samples consisting of environmental swabs. The analysis of these environmental samples found Listeria monocytogenes (L. monocytogenes) in one subsample (INV 622427) collected from your tofu processing area. L. monocytogenes is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening, illness called invasive listeriosis. It is essential that you identify all areas of your facility where L. monocytogenes is able to grow and survive (niche areas) and take such corrective actions as necessary to control the organism. FDA recommends that your sanitation controls include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination.
We acknowledge that you initiated a voluntary recall of your "Raquel's" brand products on July 23, 2010 after sampling conducted by California state authorities detected L. monocytogenes in your facility.
We found significant violations of the current Good Manufacturing Practice (CGMP) regulations for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).
1. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. 21 CFR 110.35(a). However, on April 27, 2010, our investigators observed mold on the upper west wall in the tofu processing room in close proximity to exposed tofu products, and on the pipes directly above the tofu processing tables. The operating fans near the same wall may blow mold particles which could contaminate in-process and finished tofu products and food contact surfaces.
We acknowledge your response letter, which states that the mold observed on April 27, 2010 was scrubbed down and sanitized the next day. The response also states that the plant was closed down on Apri1 29, 2010 to clean and sanitize all walls, ceilings, fans, and equipment. However, when investigators were in your facility on May 3, 2010, they noted ceiling tile near the salad room entrance that was dirty with apparent mold. Although the specific area observed on April 27, 2010 was scrubbed, there is a continued failure to maintain the facility in a sanitary condition. The observation of mold growth in or on the walls and ceilings of your plant has been observed on previous inspections in March 2006, September 2006, and January 2009 and indicates that the issue of mold growth in your plant is an ongoing problem.
2. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. 21 CFR 110.35(a). However, our investigators observed an employee in the mixing and filling room for production of hummus, a ready-to-eat product, use only water to clean the mixer, filler, plastic scoop, and spatula. The metal pipes used to transfer hummus from the mixer to the filler also were only flushed with water, and then disassembled and placed on a table. The next day, the investigators observed dried food residue on the inside surfaces of the same metal pipes. Your plant manager informed our investigators that these pieces of equipment had been cleaned and were ready for use in production; however they were not clean.
We acknowledge your response letter stating that the employee in charge of hummus production was shown that the equipment, including the mixer, filler, plastic scoop, spatula, and the metal pipes used to transfer hummus from the mixer to the filler must be cleaned with a sanitizing solution. Your response also states that a new procedure would be implemented in which the metal pipes are cleaned with a brush prior to being placed back into position for production, and the plant manager will inspect the equipment prior to the start of production. However, we find that this correction does not adequately address the noted observation in that simply rinsing the mixer, filler, plastic scoop, and spatula with water and sanitizing solution may not be adequate to remove food residue.
3. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices to protect against contamination of food. 21 CFR 110.10(b).
a. Employees must wear outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or foodpackaging materials. 21 CFR 110.10(b)(1). However, our investigators observed employees handling in-process tofu directly touching the food and food contact surfaces with their plastic sleeves and aprons. These same sleeves and aprons were then observed to be in direct contact with the side edges of the cutting tables. The employees also wore these same outer garments in between tasks of performing sanitation duties and handling in-process product.
We acknowledge your response stating that, in a May 6th meeting, all employees were told that whenever they are in contact with food and/or food surfaces, all clothing, including lab coats, aprons, plastic sleeves, etc. need to remain clean and un-torn. However, this corrective action is inadequate in that it does not address the observation that the employees wore the same outer garments while performing sanitation duties and handling in-process product.
b. The following activities must be confined 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). However, our investigators observed an employee eating an in-process hummus product directly with her gloved fingers from the in-process utensils in between mixing at least three times. Our investigators observed an employee with gloved hands cutting mangoes for the production of ready-to-eat salads. The same employee picked up a piece of mango with the same gloved hand and ate portions of the mango. Our investigators also observed an employee chewing gum while rinsing and chopping parsley for the production of a ready-to-eat salad.
We acknowledge your response states that, in an employee meeting, you "reconfirmed" your policy of "no eating or drinking on the plant floor, and no eating/touching or tasting of the WIP." Similar observations of poor employee hygienic practices have been made in a previous inspection of your facility (January 2009). The type of training given to employees does not appear adequate to ensure the problem will not recur.
4. All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. 21 CFR 110.40(a). However, our investigators observed that the currently in-use metal trays, which are used as a direct food-contact surface for tofu production, were rusted around the edges and seams, and have comers with cracks and holes.
We acknowledge your response letter stating that the metal trays will be scrubbed, submerged in sanitizing solution, and rinsed prior to each use. You also stated that you will begin a program of replacing damaged trays that will be completed within a month. This corrective action appears to be adequate.
Seafood HACCP
We also found significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. Specifically, because your firm produces refrigerated, ready-to-eat seafood products, you must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur. 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for to control the food safety hazard of pathogen growth and toxin formation.
We acknowledge your statement that you will discontinue your seafood products. However, you also stated that your current hazard analysis was sent back to your food safety consultants for improvement. These responses are inconsistent with each other. Also, your response is insufficient in that it does not state a timeframe for correction.
You also must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by the violations cited above.
Labeling of Raguel's Hummus & Dip Spicy Hummus Product
FDA also collected labels of your food products for review. Based on our review of your Raquel's Hummus & Dip Spicy Hummus ("Spicy Hummus") product label, we determined that the product it is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each ingredient. 21 CFR 101.4(b)(2). FDA investigators observed the product being manufactured with soybean oil, but the finished product label fails to declare the presence of soybean oil. Furthermore, the product label declares "olive oil," but olive oil is not used in the product and therefore may not be declared as an ingredient.
Your Spicy Hummus product is further misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not declared in accordance with the Act and FDA regulations. Specifically:
• The content of saturated fat, cholesterol, dietary fiber, sugars and vitamins and minerals are not declared. 21 U.S.C. § 403(q)(1)(D) and (E); 21 CFR 101.9(c)(2)(i), 101.9(c)(3), 101.9(c)(6)(i) and (ii), and 101.9(c)(8). If these nutrients are not present in your food and you choose to omit them from the list of nutrients, a "Not a significant source of. .." statement is required.
• The serving size declaration is not expressed in a common household measure that is appropriate to the food. 21 CFR 101.9(b). The product label declares the serving size as "1 oz. (28g)." However, for a dip, "common household measure" means tablespoons. See 21 CFR 101.9(b)(5)(i). The serving size for nondiscrete bulk products is the amount in common household measure that most closely approximates the Reference Amount Customarily Consumed (RACe) for the product category. 21 CFR 101.9(b)(2)(iii). Because the RACC for dips is 2 tablespoons, the correct serving size for your product is also 2 tablespoons. Accordingly, the serving size for your product should be declared as "2 tbsp (_ g)".
• The amount for Calories from Fat ("Fat Cal.") is not rounded to the nearest 5-calorie increment. 21 CFR 101.9(c)(1)(ii).
• The "% DV" for Carbohydrates is not rounded to the nearest whole percent. 21 CFR 101.9(d)(7)(ii).
• A "% DV" for Trans fat cannot be declared because a Daily Value for trans fat has not been established.
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. Failure to implement lasting corrective action of these violations and prevent their recurrence may result in regulatory action by FDA without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products, and the seizure of such products, under sections 302 and 304 [21 U.S.C. §§ 332 and 334].
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.
Please send your reply to the Food and Drug Administration, Attention: Juliane K. Jung-Lau, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issue in this letter, please contact Compliance Officer Jung-Lau at (510) 337-6793.
Sincerely,
/s/
Barbara J. Cassens
San Francisco District Director
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