Inspections, Compliance, Enforcement, and Criminal Investigations
Jing Sheng Company 11/19/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
November 19, 2012
Jing Yun Chen, Owner
Jing Sheng Company
140 E. Santa Clara St.
Arcadia, CA 91006
Dear Mr. Chen:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at 140 E. Santa Clara St., Arcadia, CA 91006, from July 10 to 13, 2012. Based on the information collected during our July 2012 inspection, we have determined that you have serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations, as described in more detail below. You can find the Act and regulations on FDA’s website at www.fda.gov.
During the inspection of your facility, FDA collected samples of your finished product labeled as “Naturally cooked abalone” and evidence related to the raw material you use to manufacture this finished product. Based on our analysis of this information, as well as statements you provided in an affidavit during the inspection, we have determined that your product “Naturally cooked abalone” is actually sea snail (Zidona Dufresnei) and not Abalone (family Haliotidae). Therefore, your product, “Naturally cooked abalone,” is adulterated within the meaning of Section 402(b)(2) of the Act [21 U.S.C. § 342(b)(2)] in that sea snail meat has been substituted for Abalone. Furthermore, your product “Naturally cooked abalone” is misbranded within the meaning of Section 403(b) of the Act [21 U.S.C. § 343(b)] in that it is offered for sale under the name of Abalone but is, in fact, sea snail.
Your “Naturally cooked abalone” product is also misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading. Specifically, the product label declares the package to contain Abalone when the product is, in fact, sea snail, and does not contain Abalone.
Your “Naturally cooked abalone” product is misbranded within the meaning of Section 403(i) of the Act [21 U.S.C. § 343(i)] because it is fabricated from two or more ingredients, and the label fails to declare the common or usual name of each ingredient as required by 21 CFR 101.4(b). Specifically, you fail to declare the salt which is added to your product, on your finished product label.
Your “Naturally cooked abalone” product is misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] because your product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language or foreign characters, 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.
Your “Naturally cooked abalone” product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition facts information is not declared in accordance with 21 CFR 101.9. For example:
- The serving size declaration for this product, "2.5 oz," is not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement is “_ piece(s) (_ g); _cup(s) (_g); _oz (_ g/visual unit of measure)” for your product.
- The Servings Per Container is not declared as required by 21 CFR 101.9(d)(3)(ii).
- The Calories statement is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)].
- The Calories from Fat statement is not expressed to the nearest 5-calorie increment [21 CFR 101.9(c)(1)(ii)].
- The Cholesterol statement is not expressed to the nearest 5-milligram increment [21 CFR 101.9(c)(3)].
- The Sugars statement is not declared as required by 21 CFR 101.9(c)(6)(ii).
- The Vitamin A, Calcium, and Iron statements are not declared in accordance with 21 CFR 101.9(c)(8)(iii). The percentages of vitamins and minerals must be expressed to the nearest 2-percent increment up to and including the 10-percent level.
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
Additionally, we found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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). Accordingly, your dried sea snails and dried sea cucumbers are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your serious deviations are as follows:
- You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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, to comply with 21 CFR 123.6(a) and (b). However your firm does not have a HACCP plan (or plans) for your dried fish and fishery products, including your dried sea snails and dried sea cucumbers, to control the food safety hazard of pathogen growth and potential toxin formation. The inspection revealed that these products are intended to be distributed at ambient or room temperatures (i.e., unrefrigerated) and consequently, your firm needs to ensure that you control the hazard of pathogen growth, specifically Staphylococcus aureus toxin formation from receipt of the raw materials until such time that the products achieve a water activity (Aw) or water phase salt (WPS) or percent salt concentration adequate to control pathogen growth and toxin formation.
- You must maintain sanitation control records that, at a minimum, document monitoring and to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the eight key areas of sanitation required for the processing of your dried fishery products. Specifically, during the inspection your firm was unable to produce any sanitation monitoring records.
At the conclusion of the inspection on July 21, 2012, you verbally promised our Investigator that you would immediately begin correcting the referenced violations and submit a written response to FDA within fifteen (15) days. However, as of the date of this letter, we have not received a written response from you.
In addition to the violations cited above, we have the following comments:
- The net weight is declared in U.S. Customary terms only. The net quantity of content should also be declared in terms of metric units in accordance with 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA).
- Your Naturally Cooked Abalone product label states, “Keep Frozen”; however, the product is refrigerated or stored at room temperature. The product label should bear the proper safe handling direction, in order to not appear misleading.
- The statement of identity for your Naturally Cooked Abalone product includes the language “Naturally Cooked.” The reference to “Naturally Cooked” is potentially misleading and could, therefore, be confusing to the consumer.
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
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 domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations or documentation to establish that correction has been achieved. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with all applicable laws and regulations, including the Act, the seafood HACCP regulation (21 CFR Part 123.6) and Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Blake Bevill, 19701 Fairchild, Irvine, California 92612. If you have questions regarding any issues in this letter, please contact Mr. David Serrano, Acting Compliance Officer at 909-390-7860 x112 or Mr. Blake Bevill, Director of Compliance Branch at 949-608-4426.
Alonza E. Cruse
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-741