https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sheng-kee-california-inc-dba-sheng-kee-bakery-668255-04242024
Sheng Kee of California, Inc dba Sheng Kee Bakery
MARCS-CMS 668255 — APRIL 24, 2024
Recipient:
Mr. Siau Liang "Mark" Kao
President
Sheng Kee of California, Inc dba Sheng Kee Bakery
201 S Hill Dr
Brisbane, CA 94005
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
April 24, 2024
Dear Mr. Kao:
The United States Food and Drug Administration (FDA) inspected your manufacturing and distributing facility, located at 201 S Hill Dr, Brisbane, CA 94005, on August 14 through 31, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) and non-RTE bakery products manufactured in your facility 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 become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the Preventive Controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
In addition, your Egg Bread product is also adulterated under section 402(c) of the Act [21 U.S.C. § 342(c)] because it contains color additives which are unsafe within the meaning of section 721(a) of the Act [21 U.S.C. §379e(a)].
Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products described below to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
You may find the Act and further information through links on FDA's website at http://www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided a response to the inspection on September 21, 2023, describing corrective actions taken by your firm. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:
1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).
However, you did not have a food safety plan with any of the required elements. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically:
a. You did not identify and evaluate allergens as a known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Your facility manufactures RTE and non-RTE bakery products that contain allergens such as egg, soy, wheat, milk, sesame, peanuts and tree nuts. Allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label, as required by 21 CFR 117.135(c)(2)(ii).
You do not perform and document the review of labels for proper declaration of allergens. For example, on August 15, 2023, FDA observed your employees apply an egg wash to your two Cantonese-style mooncake lines, producing Lotus Mooncake and Red Bean Mooncake. You did not identify egg as an ingredient in your product labels for Assorted Mini Moon Cake (9 PCS), Assorted Mini Moon Cake (12 PCS), Assorted Large Moon Cake (4 PCS), and Assorted Large Moon Cake (4 PCS/TIN PACK). As a result, your firm recalled these products on September 1, 2023.
b. For your RTE bakery products, you did not identify environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Your facility manufactures RTE bakery products which are exposed to the environment after baking and handled by employees prior to packaging. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR § 117.135(c)(3)). In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)). In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventative control (see 21 CFR § 117.165(a)(3)). You are not performing environmental monitoring to evaluate the effectiveness of your sanitation practices regarding employee practices and cleanliness of food contact surfaces.
c. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures bakery products from wheat, soy and tree nuts. These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/ processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). You do not have this program in place.
We received your response to the FDA Form-483 on September 21, 2023, in which you state that two employees will first be trained in GMP and 21 CFR § 117, then these employees will plan on writing up a list of sanitation controls, environmental monitoring program, and a food safety plan. Your response is not adequate because you have not yet established a food safety plan to address the above known or reasonably foreseeable hazards for your RTE bakery products nor provided evidence of how you will temporarily control for these hazards until a food safety plan can be established.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not take effective measures to exclude pests from the food plant to protect against the contamination of food on the premises by pests, as required by 21 CFR § 117.35(c). Specifically,
a. On August 15, 2023, the FDA investigator observed apparent flying insects in mixing bowls, which employees planned to use for a cold dessert mix.
b. On August 14, 2023, the FDA investigator observed numerous apparent flying insects in the ambient warehouse where the firm stores ingredients, food products, processing equipment, and various other items, and the large loading door was left open directly to the outdoors during operational hours. In addition, flying insects were observed in each of the production rooms where food was being processed.
c. On August 14, 2023, the FDA investigator observed apparent insects crawling on the floor near a pile of flour underneath your flour silo and observed apparent live spiders in your ambient storage warehouse, Recipe/Prep Room and in the Electrical Room where you store ingredients.
On September 21, 2023, your firm provided a response to the FDA Form-483, in which your firm stated you are working with (b)(4) or other third-party companies to assist you in addressing the issues. This response is not adequate because you have not provided evidence or supporting corrective action documentation that you have excluded pests from your facility and from contaminating food.
2. You failed to take reasonable measures or precautions related to personnel practices, as required by 21 CFR § 117.10. Specifically,
a. On August 14, 2023, FDA observed that your employees were storing personal belongings, including personal clothing, cell phones and water bottles, in the production areas where food is exposed, in violation of 21 CFR § 117.10(b)(7). FDA also observed a partially eaten bag of crackers in the washroom on top of the (b)(4) where equipment was being cleaned.
b. On August 17, 2023, one employee was observed applying egg wash and sprinkling sesame on Egg Bread, then checking his cell phone, and returning to applying egg wash and sprinkling sesame without washing his hands, in violation of 21 CFR § 117.10(b)(3).
On September 21, 2023, your firm provided a response to the FDA Form-483, in which your firm stated you have asked your employees as well as posted a memo regarding personal objects in your work areas. Your response additionally stated that you retrained the managers to watch for these personnel practices and to conduct audits. In addition, you plan to create a training module for handwashing that you plan to train the whole production team. This is not adequate because you have not provided evidence that you have trained your employees, including the managers, nor have you provided examples of personnel audits.
3. You failed to clean non-food contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically:
a. On August 17, 2023, the FDA investigator observed that cutting and application utensils were stored against the wall, hung on a discolored and dirty metal pipe.
b. On August 14, 2023, the FDA investigator observed the steel frame shelves used to store clean bowls, utensils, containers, ingredients, and equipment in your production rooms and storage areas were unclean and had accumulated debris or residue on their surfaces. The investigator also observed employees grabbing mixing bowls and using them without additional cleaning.
c. On August 15, 2023, the FDA investigator observed the interior of your (b)(4), specifically the internal machine components under the lid, had accumulated a large amount of blackened residue and debris, and there was also an apparent dead spider.
On September 21, 2023, your firm provided a response to the FDA Form-483, in which your firm stated you have started conducting deep cleaning for racks and machines. Your response states that you plan to ask your suppliers to arrange cleaning training on your specialty equipment during the next (b)(4) maintenance visits, and plan to conduct some large warehouse cleaning actions. Although you have provided photographs indicating you have cleaned some machines, you have not provided evidence regarding the pipe upon which utensils were stored.
4. You did not store and transport food under conditions that protect against allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR § 117.93. Specifically,
a. On August 14, 2023, I observed a bag of raw onions stored on the floor of your cooler room. I also observed various food containers being stored on the floor in the storage and processing areas, including pails of chocolate powder and pails of filling/paste for bread and cakes.
b. On August 17, 2023, the FDA investigator observed blocks of chocolates, to be used as chocolate shavings on top of RTE cake, stored against the wall on a table and in direct contact with a dirty electrical cable.
On September 21, 2023, your firm provided a response to the FDA Form-483, in which your firm stated you moved the chocolate to a different area and cleaned the electrical wire. However, you have not provided evidence that such actions were taken.
5. Your plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept in good repair, as required by 21 CFR § 117.20(b)(4). Specifically, during the inspection of your facility, the FDA investigator observed apparent black residue on walls, ceilings and floor in the production room, coolers, freezers, blast freezer and ambient warehouse. The black material was also present in washroom and cake room where sanitation is performed, including on sinks and near sanitizer dispensers.
On September 21, 2023, your firm provided a response to the FDA Form-483, in which your firm stated you are waiting for quotes and estimates to clean and sanitize the facility, and that you plan to start removing debris from the facility in October. If you have implemented corrective actions, you may submit documentation of such in your response to this letter. We will verify your corrections during our next inspection.
Color Additive Adulteration
Your Egg Bread and Green Tea & Milky Pudding products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that certified color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)].
Your Egg Bread product is manufactured with (b)(4) which contains FD&C Yellow No. 5; however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement.
Your Green Tea & Milky Pudding product is made using a Green Tea Flavored Powder which is labeled to contain Tartrazine (which may be certified as FD&C Yellow 5); however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement.
Misbranded Foods
1. Your Assorted Mini Moon Cake (9 PCS), Assorted Mini Moon Cake (12 PCS), Assorted Large Moon Cake (4 PCS), and Assorted Tea Flavor Mini Moon Cake products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act. Specifically, your Assorted Mini Moon Cake (9 PCS), Assorted Mini Moon Cake (12 PCS), Assorted Large Moon Cake (4 PCS), and Assorted Tea Flavor Mini Moon Cake do not declare the allergen of eggs from the egg wash used on all moon cakes.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]: or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
2. Your Egg Bread and Green Tea & Milky Pudding products are misbranded under section 403(k) of the FD&C Act [21 U.S.C. § 343(k)] because the products contain artificial coloring and fail to bear labeling stating that fact. Specifically:
Your Egg Bread product is manufactured with (b)(4) which contains FD&C Yellow No. 5 and FD&C Yellow No. 6 as ingredients; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(1).
Your Green Tea & Milky Pudding product is manufactured using Green tea flavored powder ingredient. This ingredient declares “Tartrazine (E102) and Brilliant blue FCF (E133)” on its product label; however, the “Green Tea & Milky Pudding” product does not declare these color additives as required by 21 CFR 101.22(k).
The Egg Bread ingredient list declares calcium propionate; however, the preservative function is not declared in accordance with 21 CFR 101.22(j).
3. Your Assorted Mini Moon Cake (9 PCS), Assorted Tea Flavor Mini Moon Cake (12 PCS), and Assorted Large Moon Cake (4 PCS) products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because:
The product labels contain information in a foreign language, but do not repeat all the required information in all languages as required by 21 CFR 101.15(c)(2). The net quantity of contents and Nutrition Facts (such as “Includes Added Sugars”) must be on the labels in all languages used on the labels. Further, for the Assorted Large Moon Cake (4 PCS), the ingredient list, Nutrition Facts label, firm addresses, and the net quantity of contents are not provided in the foreign language.
The statement of identity on the Assorted Mini Moon Cake (9 PCS) and the Assorted Large Moon Cake (4 PCS) is not provided in English on the Principal Display Panel (PDP). [21 CFR 101.15(a) and (c)(1)].
The Mini Moon Cake (9 PCS), Assorted Large Moon Cake (4 PCS) and Assorted Tea Flavor Mini Moon Cake (12 PCS) labels do not declare the net quantity of contents in English on the PDP. [21 CFR 101.15(c)(1) and 21 CFR 101.7(a)].
The allergen “Contains” statements on the sticker labels are not placed immediately following or adjacent to the ingredient lists on the Assorted Large Moon Cake (4 PCS) and Assorted Tea Flavor Mini Moon Cake (12 PCS) as required by section 403(w)(1)(A) of the Act.
4. Your Egg Bread is misbranded within the meaning of section 403(a)(1) of the Act [(21 U.S.C. § 343(a)(1)] because its labeling is false or misleading. Specifically, the major food allergen, sesame, is declared in the ingredient list and the label includes a Contains statement but sesame is not declared in the Contains statement. We note that if a “Contains” statement is used on a food label, the statement is to include the names of the food sources of all major food allergens used as ingredients in the packaged food. More information on Food Allergen Labeling Requirements and the “Contains” statement can be found in the publication “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.”
5. Your Assorted Tea Flavor Mini Moon Cake (12 PCS), the Assorted Mini Moon Cake (9 PCS), the Assorted Large Moon Cake (4 PCS), and the Egg Bread products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR § 101.4. For example,
The Assorted Tea Flavor Mini Moon Cake (12 PCS) and Assorted Mini Moon Cake (9 PCS) products are made using “Cake Flour,” a multi-component ingredient; however, the sub-ingredients of the Cake Flour are not declared.
The Assorted Tea Flavor Mini Moon Cake (12 PCS) and Assorted Mini Moon Cake (9 PCS) ingredient lists declare “Baking powder,” a multi-component ingredient; however, the sub-ingredients are not declared.
Numerous ingredients in the Assorted Tea Flavor Mini Moon Cake (12 PCS), the Assorted Mini Moon Cake (9 PCS), the Assorted Large Moon Cake (4 PCS), and the Egg Bread ingredient lists are not declared by appropriate common or usual names (21 CFR § 101.4(a)(1) and use collective parenthetical listings, for example, “Cooked Syrup” and “emulsifiers,” which are not provided for in 21 CFR § 101.4(b).
Further, the Egg Bread ingredient list includes multi-component ingredients that are not appropriate common or usual names and note that they may be brand names, which are not permissible ingredient names: “Antinoxidantnon,” “Baker syrup,” “S-Kimo,” “Soft’R intens fresh,” “Verv lactylate,” and “Expando powder.”
The Assorted Mini Moon Cake (9 PCS), Assorted Tea Flavor Mini Moon Cake (12 PCS), and the Assorted Large Moon Cake (4 PCS) ingredient lists do not declare the eggs that are used in the egg wash used on these products.
According to 21 CFR § 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR § 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR § 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
This letter is not intended to be an all-inclusive statement of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct all the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to do so may result in legal action including, without limitation, seizure and injunction.
We also offer the following comments:
The nutrition facts label on your Assorted Mini Moon Cake (9 PCS), Assorted Tea Flavor Mini Moon Cake (12 PCS), and Egg Bread products is not as defined in 21 CFR 101.9. Specifically,
o The declared increments for Calories, Total Fat and Saturated Fat in the Assorted Tea Flavor Mini Moon Cake (12 PCS) and Assorted Mini Moon Cake (9 PCS) products are not as required by 21 CFR 101.9(c)(1), 21 CFR 101.9(c)(2), and 21 CFR 101.9(c)(2)(i), respectively.
o The declared increments for Calories, Saturated Fat, Vitamin D, and Iron in the Egg Bread product are not as required by 21 CFR 101.9(c)(1), 21 CFR 101.9(c)(2)(i), and 21 CFR 101.9(c)(8)(iii), respectively.
The name of your Assorted Tea Flavor Mini Moon Cake (12 PCS) and Egg Bread products are not consistent. For example, the name of the product on the principal display panel does not match the name shown on the information panel, see 21 CFR 101.3.
We question the household unit of measure declaration for the Egg Bread product (“1 slice”) as it’s not clear if the product is pre-sliced. If the product is not pre-sliced, the consumer would not be aware of what a slice should look like. If it is not pre-sliced, the thickness of the slice needs to be provided as part of the serving size.
For your moon cakes, if the ingredients, “Green tea paste,” “Green tea chestnut paste, “Pomelo paste,” “Date paste,” “lotus seed paste,” and “red bean paste” are multi-component ingredients, they should also include a sub-ingredient listing.
All mooncake product labels include an advisory statement: “is manufactured in a facility that may process products that contain Tree nuts (e.g., Walnut, Pinenut), Milk, Egg.” The allergen labeling requirements in the FD&C Act do not address advisory labeling, including the presence of unintentional substances in food products resulting from the food manufacturing process. FDA has maintained that advisory labeling must not be used in lieu adherence to Good Manufacturing Practices (GMPs) or Preventive Controls.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Pkwy
Alameda, CA 94502
Refer to Unique Identification Number 668255 when replying.
If you would prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification Number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations West Division 5
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