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  5. Sunrise Noodle Corp. - 12/11/2015
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WARNING LETTER

Sunrise Noodle Corp.


Recipient:
Sunrise Noodle Corp.


United States

Issuing Office:
Baltimore District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707

 

WARNING LETTER
CMS # 484704
 
December 11, 2015
 
VIA UPS
 
Mr. Jim Hsu, President
Sunrise Noodle Corporation
1016 Seaboard Avenue
Chesapeake, VA 23324
 
Dear Mr. Hsu:
 
The Food and Drug Administration (FDA) conducted an inspection of your flour and salt noodle manufacturing facility located at 1016 Seaboard Avenue, Chesapeake, VA 23324 from September 22, 2015 through September 25, 2015. During the inspection, we found significant violations within the Current Good Manufacturing Practices (21 CFR 110) regulations. Accordingly, it was determined that your firm’s noodle products are adulterated within the meaning of 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 they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
 
(b)(3)(A) 
 
Adulterated Food
 
Specifically, our inspection of your facility revealed the following violations:
 
1)    Failure to provide adequate screening or other protection against pests, as per 21 CFR 110.20(b)(7). During the current inspection, rodent excreta pellets (REPs) too numerous to count were observed in your cutting room and in your storage warehouse. A dead rat was observed under an empty pallet on the floor of your storage warehouse, and an approximately 3-4 inch hole was observed at the base of the roll up door of the warehouse. This is a repeat observation from a July, 2015 Virginia Department of Agriculture and Consumer Services (VDACS) inspection.
 
2)    Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food packaging materials, as per 21 CFR 110.35(a). During the current inspection, dried old food residue was observed on your mixer, cutter and noodle press. Mildew and flaking paint were observed on your walls and ceiling located in the drying room. Also, your racks and PVC pipes that are used to hold drying noodles were observed to be encrusted with apparent mildew and filth in the inner tuning of the PVC pipes. Your racks were observed with a build-up of apparent grease/oils and dirt while observed in use. Additionally, spider webs, too numerous to count, were found in various places throughout your firm.
 
3)    Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food packaging materials, as per 21 CFR 110.20(b)(6). During the current inspection, 8 floor fans and 3 ceiling fans were observed blowing air onto food products while the fan blades were observed with dust and dirt. This is a repeat observation from a July, 2015 Virginia Department of Agriculture and Consumer Services (VDACS) inspection.
 
4)    Failure to remove litter and waste and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as per 21 CFR 110.20(a)(1). For example, old equipment and pallets were stacked against the south side of your building next to the roll up door with a hole approximately 3-4 inches in its base. Additionally, the lawn adjacent to the parking lot in close proximity of your building was observed with high grass and weeds. This is a repeat observation from a July, 2015 Virginia Department of Agriculture and Consumer Services (VDACS) inspection.
 
5)    Failure to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated, as per 21 CFR 110.35(a). For example, insulation and ceiling material was observed hanging from the ceiling in your dry goods warehouse within 20 feet of salt storage and 5 feet from flour storage. 
 
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the FD&C Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction. 
 
Section 743 of the FD&C Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)).
 
For a domestic facility, FDA will assess and collect fees for re-inspection-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 FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence.  You should include in your response documentation and other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed. 
 
Please send your reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice by phone at 410-779-5463 or by email at david.rice@fda.hhs.gov.
 
Sincerely,
/S/                                                           
Evelyn Bonnin
District Director
Baltimore District Office