Inspections, Compliance, Enforcement, and Criminal Investigations
Chan Yee Jai 7/2/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
July 2, 2013
VIA EXPRESS DELIVERY
Ms. Christine Chan, President
Chan Yee Jai
49 Wong Chuk Hang Rd.
Wong Chuk Hang
Reference No. 398195
Dear Ms. Chan:
The U.S. Food and Drug Administration (FDA) inspected your food facility located at 49 Wong Chuk Hang Rd., Wong Chuk Hang, Hong Kong, on March 5 and 6, 2013. During that inspection, we found that your firm had serious deviations from the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110, Code of Federal Regulations, Part 110 (21 CFR Part 110). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, that listed the deviations found at your firm. You informed us during the inspection that you would not be making any corrections.
Based on the inspection findings, your food 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 have been prepared, packed, or held under insanitary conditions whereby the food may have been contaminated with filth or may have been rendered injurious to health.
In addition, during the inspection, our investigator collected copies of your product labels. Your Almond Cake product is misbranded within the meaning of Section 403 of the Act, 21 U.S.C. 343. You may find the Act and FDA’s regulations through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
Good Manufacturing Practices
1. Your firm failed to have backflow protection from piping systems that discharge waste water as required by 21 CFR 110.37(b)(5). Specifically, no backflow prevention devices were observed at any of the sinks at the facility. In addition, a non-food grade hose with no backflow prevention device was used for food manufacturing and cleaning operations.
2. Your firm failed to have sanitary towel or suitable hand drying devices as required by 21 CFR 110.37(e)(3). Specifically, there was no sanitary towel service or suitable hand drying devices in the toilet or at sinks at the facility; employees used reusable towels that appeared dirty to dry their hands.
3. Your firm failed to use equipment and utensils that allowed for proper cleaning as required by 21 CFR 110.40(a). Specifically, the tables and utensils using for processing almond cookies were constructed of wood that cannot be properly cleaned, and the wooden tables used for almond cake production had grooves with product residue in them.
4. Your firm failed to take necessary precautions to protect against contamination of food, food contact surfaces and food packaging systems with foreign substances as required by 21 CFR 110.10(b)(9). Specifically, cardboard that was attached to the air vent to deflect the air was observed hanging over exposed food product and water. In addition, plastic tape that was observed to have residue on it was used on a noodle machine and came in direct contact with food product.
5. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the windows in the processing area were open and unscreened, and flies were observed in the food processing area.
6. Your firm failed to take reasonable precautions to ensure that production procedures did not contribute contamination from any source as required by 21 CFR 110.80. Workers were seen eating on tables used for processing and the tables were not cleaned prior to resuming work.
7. Your firm failed to maintain buildings and physical facilities in sufficient repair to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Specifically, the walls and ceiling in the processing/packing facility had peeling paint directly over a conveyor belt that was used to transport exposed food and over boxes used to pack food.
8. Your manufacturing employees failed to remove unsecured jewelry or other objects which might fall into food, equipment, and containers as required by 21 CFR 110.10(b)(4). Specifically, employees were observed wearing wrist watches and bracelets while they were manufacturing your food products.
1. Your Almond Cake product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information is not declared as required by 21 CFR 101.9. For example:
- The product label does not declare a serving size or servings per container (21 CFR 101.9??)
- The product label does not declare the calories per serving or calories per serving from fat [21 CFR 101.9(c)(1)]
- The product label does not declare the Daily Reference Value (DRV) for those substances for which a DRV has been established, such as fat, carbohydrates, and sodium [21 CFR 101.9(c)(9)]
- The product label does not declare the vitamins for which an RDI has been established, or bear the statement identifying that the product is not a significant source of the nutrients [21 CFR 101.9(c)(8)]
2. Your Almond Cake product is further misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] in that the product label contains information in more than one language but does not repeat all of the required information in all languages. In accordance with 21 CFR 101.15(c)(2), if a product label contains any representations in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The label for your Almond Cake products bears some of the required information in English, French, and Chinese, but does not bear all of the required information in all three languages.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your products under Section 801(a) of the Act (21 U.S.C. 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts which can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the CGMP regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Additionally, 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 foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Carol D’lima, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Carol.Dlima@fda.hhs.gov. Please reference case id #398195 on any submissions and within the subject line of any emails to us. You may also contact Carol D’lima at (240) 402-2033 or email if you have any questions about this letter.
Office of Compliance
Center for Food Safety
and Applied Nutrition