Inspections, Compliance, Enforcement, and Criminal Investigations

Shining Marble Inc dba Shil La Dang 9/30/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax            (949) 608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                            
 
September 30, 2016
WL# 52-16
Mr. Seong H. Kim, Owner
Shining Marble, Inc.
2306 W. Rosecrans Ave.
Gardena, CA 90249-2908
                                                                                                                                               
Dear Mr. Kim:
                                                           
On July 25, 2016 - August 5, 2016, the U.S. Food and Drug Administration conducted an inspection of your  food and seafood facility, located at 2306 W. Rosecrans Ave., Gardena, California We found that you have serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, and the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 110 and 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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). The inspection also revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, at 21 CFR Part 110. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm's food products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4))], in that they have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. Accordingly, your fried fish cake sushi roll and Korean rice cake products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health.    
 
You may find the Act, CGMP regulation, seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
We acknowledge the receipt of your response on August 23, 2016 to the FDA 483 that was issued to you on August 5, 2016. We have reviewed your response, and have determined it to be inadequate since it did not contain a developed HACCP plan or any supporting documentation for the stated corrective actions that were made.
 
Your significant violations are as follows:
 
HACCP Violations:
 
1.    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 for the ready-to-eat Shil La Dang Seaweed Rice Roll to control the food safety hazards of pathogen growth/toxin formation and allergens.
 
Please refer to Chapter 19 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical limits, monitoring procedures and critical control points to control the hazard of undeclared allergens. Please refer to Chapter 12 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical limits, monitoring procedures and critical control points to control the hazards of pathogen growth/toxin formation.
 
2.    You 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 condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by our investigator observing the following:
 
a)  Prior to the start of processing of rice roll, there were excessive old food residues and grime on the roller, equipment joints, and the conveyor belt of the sushi rolling machine. The sushi rolling machine was not cleaned and sanitized prior to using.
 
b)  The sushi cutting machine was heavily encrusted with old, dried and greasy food residue on its blades and throughout the area where the ready-to-eat sushi rolls came in direct contact. Also, the white plastic press that is used for pushing the sushi roll through the knife blades had numerous knife marks and brown residues on it. This sushi cutting machine was not cleaned and sanitized prior to using.
 
c)  An employee was observed stacking stainless steel trays containing exposed sliced radishes on Styrofoam trays on top of each other. The soiled tray bottoms come in direct contact with the sliced radishes. These stainless steel trays also had thick brown food residues along the edges surrounding the entire tray. These metal trays were stored on the kitchen counter or on the soiled tray rack during the inspection. Observed the owner placing used trays back on the kitchen counter for later use without first washing or sanitizing them.
 
d)  A live roach was observed running onto the side of the shelf that was next to the sushi processing table. Exposed sushi roll ingredients such as seasoned fish cake, cucumber, yellow radish, and shredded carrot were on the processing table.
 
e)  A live fly was observed landing on grinded rice in the production area, and a flying inspect and two ants were observed on bags of broken rice in the dry storage area.
 
3.    You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions and exclusion of pests required for the processing of Shil La Dang Seaweed Rice Roll containing fried fish cake.
 
cGMP Violations:
 
4.    You must conduct all food manufacturing, including packaging and storage, under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR Part 110.80(b)(2). However, our investigator observed the following:
 
a.  Manufactured ready-to-eat rice cakes were stored and distributed without refrigeration. These products are not shelf-stable.
 
b.  Prior to the start of processing of rice cake, the rice cake forming machine was excessively soiled with old, discolored food residue. The rice cake forming machine was later used to make ready-to-eat rice cake. The machine was not cleaned and sanitized prior to being used.
 
c.  Prior to the start of processing of rice cake there were old sticky food residue and black grime accumulation at the food contact surfaces, non-food contact surfaces, and around equipment joints near the roller of the rice cake rolling machine.
 
d.  Three brown plastic containers used to collect grinded rice from the grinder were stored directly on the processing room floor. An employee was observed picking up one plastic container and stacking directly on top of the other two tubs containing grinded rice.
 
e.  A stainless steel tray containing steamer pan was observed being stored directly on the processing room. An employee was observed placing this stainless steel tray on top of two plastic tubs containing grinded rice that was also placed on the floor.
 
f.  Plastic containers used to store grinded rice were placed directly on the production room floor between uses and then the containers were stacked on top of each other so that the soiled container bottoms come in direct contact with the food contact surfaces of the interior of the container below it. An employee then placed the stacked containers on top of a hopper of the rice grinder.
 
g.  An employee was observed wearing cloth gloves that are not easily cleanable while handling ready-to-eat rice cake. The cloth gloves appeared to have visible stains and were in direct contact with the ready-to-eat rice dough used to make rice cake.
 
h.  A tray containing ready-to-eat rice cake came in direct contact with an electric cord that was visibly soiled with old food residue and dirt buildup.
 
i.  A far covered in dust and grime was observed blowing onto uncovered ready-to-eat rice cake and shredded carrot.
 
j.  Plastic bags covered the control panel and motor of the rice cake forming machine were soiled with old product build up and dirt. The production employee’s hands were in direct contact with the plastic liner during processing to turn on and turn off the equipment.
 
5.    All persons working in direct contact with food components or food-contact surfaces must use hygienic practices, including washing hands thoroughly (and sanitize if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility before starting work and at any time when the hands may have become soiled or contaminated, to protect against contamination of food components or food-contact surfaces, as required by 21 CFR Part 110.10(b). However, our investigator observed the following:
 
a.  An employee processing ready-to-eat rice cake was observed rubbing his nose with his gloved hand and then continuing to process the rice cake without washing and sanitizing his hands or changing his gloves. His gloved hands came into direct contact with the ready-to-eat rice cake.
 
b.  An employee was observed wearing cloth gloves while cleaning the rice cake rolling machine. The employee then continued to wear the same pair of cloth gloves to handle ready to eat rice cake. The employee’s gloved hands came into direct contact with the ready-to-eat rice cake.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
You should 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. 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.
 
Also, Nutrition labeling is required by Section 403(q)(1) of the Act (21 U.S.C. 343(q)(1)) and 21 CFR 101.9. Your firm may qualify for an exemption from nutrition labeling under the regulations for small business based on low volume sales/number of employees. Your firm was not found on the list of firms that submitted for exemption from nutrition labeling.   The web-based submission process can be found at the following: https://www.accessdata.fda.gov/scripts/NLE/client/login.cfm.  
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (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 Food and Drug Administration, Attention: 
 
Kelly D. Sheppard, Director
Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
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. 
 
If you have questions regarding this letter, please contact Rochelle A. Rolnik, Acting Compliance Officer, at 949-608-4496.
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
Cc:      
David M. Mazzera, Ph.D.
Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413

Page Last Updated: 10/21/2016
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