Inspections, Compliance, Enforcement, and Criminal Investigations

NYWP Enterprise LLC. 12/9/14

  

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

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
 

Telephone: 215-597-4390 

 

WARNING LETTER
15-PHI-04
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
                                                                       
December 9, 2014
 
Juan Qing Lin, Co-Owner
New Yung Wah Trading Company
311 Richardson Street
Brooklyn, New York 11222
 
Dear Mr. Zheng:
 
The U.S. Food and Drug Administration (FDA) inspected your multiple food warehouse, NYWP Enterprise LLC, located at 1300 Island Avenue, McKees Rocks, PA, on October 15, 2014 through October 30, 2014. The inspection found significant violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products stored at your facility to be 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 been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
 
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to Jesse Zheng at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
 
1.    As required by 21 CFR 110.35(c), you must not allow pests in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators visually observed the following evidence of a lack of pest control as follows:
 
  • On October 15, 2014, in cooler #2, located adjacent to the east side of the facility, an apparent active rodent nest containing multiple rodents was observed in a plastic lined box containing thawing rib meat, being stored on top of approximately 20/10 lb. Winter Melons, inside a 4 foot x 4 foot x 4 foot cardboard container placed in a wooden pallet.
  • On October 15, 2014, on the 1st floor of the facility, four (4) apparent rodent carcasses were observed, along the south, east and north walls of the facility and birds were observed throughout the warehouse. On October 16, 2014, birds were observed flying through the facility and landing and defecating on stored food products. On October 20, 2014, birds were observed throughout the warehouse, one (1) apparent rodent carcass was observed on the first floor, two (2) apparent rodent carcasses on the second floor, and one (1) apparent rodent carcass was observed in the courtyard. On October 21, 2014, birds were observed flying through the facility and were landing and defecating on stored food products. On October 15, 16, 20, and 21, 2014, birds were observed throughout the dry storage area landing and defecating on stored food products.
  • On October 15, 2014 and October 16, 2014, in cooler #2 located adjacent to the east side of the facility, a pallet containing twenty (20) cartons with six (6) (b)(4) brand pineapples in each, was observed to have what appeared to be possible gnaw holes on the top cartons. Inside these cartons there were shavings of the cardboard material and pineapple leaves that appeared to be nesting material. In addition, our investigators observed what appeared to be rodent excreta inside these cartons.
  • On October 15, 2014 and October 16, 2014, in cooler #2 located adjacent to the east side of the facility, what appeared to be rodent excreta was observed throughout the cooler, specifically along the north and east side walls.
  • On October 16, 2014, in the dry storage area, what appeared to be rodent excreta was observed on pallets of stored food products near the entrance, which lead a path to a hole inside a bag of flour which appeared to be a rodent gnaw hole. In addition, there was apparent rodent excreta found in the center of the dry storage area as well as along the north, east, and west walls of the facility on October 15, 16, 20, and 21, 2014.
  • On October 15, 2014, adjacent to the west side of the dry storage area, a pallet containing 45/50 lb. bags of monosodium glutamate was observed containing what appeared to be rodent excreta throughout the plastic wrapping of the products and on the top of the pallet. Additionally, there appeared to be nesting material on the top of the pallet and under a black light, possible rodent urine stains on the paper bags of monosodium glutamate.
  • On October 20, 2014, what appeared to be rodent excreta, nesting material, and rodent gnaw marks were observed on single service food products, on the 2nd floor of the facility. 
2.    Your firm failed have plumbing that is properly installed and maintained to provide adequate floor drainage, as required by 21 CFR 110.37(b) (4). Specifically, on October 15, 2014, our investigators observed standing water when entering cooler #2, adjacent to openly stored produce. The water was unable to drain properly from the cooler as a result of a clogged drain, and the floor was not constructed in a manner that allowed the water to reach the drain. These conditions were brought to the attention of Mr. Zheng on October 15, 16, and 20, 2014; however, the produce continued to be stored in the same manner with no corrective action taken to remove the standing water.
 
3.    Your firm failed to use rodenticides without observing necessary precautions and restrictions to protect against contamination of food, food-contact surfaces, and food-packaging, as required by 21 CFR 110.35(c). Specifically, on October 14, 2014, our investigator observed openly placed rodenticide in the dry storage area along the west, east, and north walls. This rodenticide was placed on plastic plates next to stored food products along the exterior walls of the facility.
 
4.    Your firm failed to take proper precautions to reduce the potential for contamination of food, and food-packaging materials with microorganisms, chemicals, filth, and extraneous material, as a result of deficiencies in plant size, construction, and design, as required by 21 CFR 110.20(b)(2). Specifically, 
 
  • The southwest side of the facility had access holes for piping that were cut through the exterior wall to allow the compressor lines for the interior refrigeration units. The access holes were secured using duct tape to seal the additional space between the piping and the facility wall.
  • In the Courtyard on the exterior of the facility facing the south and north walls, multiple pest access points were observed in the building to include broken windows, holes in the exterior of the building, breeze louvers, open air ducts, and random drain pipes that were connected.
  • The exterior of the south wall, adjacent to a low lying area of stagnant water, a series of generators were stored under an exposed overhang connected to the facility. The pipes from the series of generators enter the facility through an approximate 24” x 18” square hole. Directly inside the facility, finished product was observed to be stored.

5.    Your firm failed to have adequate drainage of areas which may contribute to contamination of food by providing a breeding place for pests, as required by 21 CFR 110.20(a)(3). Specifically, directly adjacent to the generator storage area, a low lying area filled with standing water, marshy soil, and large rocks was observed by our investigators. This area continues alongside of the exterior perimeter of the building and can provide a harborage area and water source for pests.

6.    Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, building material, used equipment and vehicle parts were observed in an exterior enclosed courtyard separating the two sections of the warehouse. Adjacent to this area, on the north wall of the courtyard, our investigators observed what appeared to be rodent tracks and a dead rodent carcass.

7.    Your firm failed to construct your plant in such a manner as to allow aisles or working spaces between equipment and walls, and that they are unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food, as required by 21 CFR 110.20(b)(4). Specifically, on the north wall of the dry storage area, pallets storing food products were stacked approximately two high and six to eight deep, covering an area of approximately 3000 square feet. The pallets were stacked directly against one another, which did not allow adequate spacing to inspect or observe possible rodent activity. 

8.    Your firm failed to store single-service articles in a manner that protects against contamination of food and food-contact surfaces, as required by 21 CFR 110.35(d)(4). Specifically, in the dry storage area of the facility, three (3) buckets were observed collecting water, draining from a leak in the rood. The buckets were placed on top of single service food related items that are distributed for sale. Additionally, the exterior packaging of these items was observed to be wet and deteriorating.

9.    Your firm failed to provide safety-type light bulbs and lighting fixtures that are suspended over exposed food, as required by 21 CFR 110.20(b)(5). Specifically, the light fixtures in cooler #2 and freezer #3 were observed to be exposed and unprotected with food items being stored directly under them.

10.    Your employees failed to confine the use of tobacco to areas other than where food may be exposed, as required by 21 CFR 110.10(b)(8). Specifically, on October 21, 2014 in front of freezer #3, two (2) employees were observed smoking while handling food products for distribution. 

This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You should take prompt action to correct the violations described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, including but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.

Further, 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 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 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 Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
We acknowledge receipt of your November 19, 2014 written response to the FDA Form-483 Inspectional Observations, issued to your firm on October 30, 2014. This response states that your firm has aggressively addressed the deviations noted above, and that your goal is to attain voluntary compliance with all applicable laws and regulations to ensure safe storage and handling of all products in your facility. Despite this, FDA has serious concerns that our investigators found your firm operating under these conditions. Further, your response states that your firm is committed to maintaining and operating a facility which provides the highest quality service to its customers and to the consuming public. We do not consider this response acceptable because you failed to provide documentation for our review, which demonstrates your noted corrective actions. This documentation may include photographs, invoices, work orders, voluntary destruction records, certification of actions performed by a licensed exterminator, other actions performed to control unauthorized entrance of pests, and/or any other useful information that would assist us in evaluating your corrections. 
 
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. 
 
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address on this letterhead. If you have any questions about this letter, please contact Ms. Bonner at 215-717-3074 or email her at Lynn.Bonner@fda.hhs.gov.                                                                          
 
Sincerely,
/S/ 
Anne E. Johnson 
Acting District Director   
Philadelphia District
  
 
cc:       
Jessie Zheng, Co-Owner
New Yung Wah Trading Company
311 Richardson Street
Brooklyn, New York 11222
 
Bao Ping Zheng, Manager
NYWP Enterprise LLC.
1300 Island Avenue
McKees Rocks, PA 15136-2578
 
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408

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