WARNING LETTER
NYWP Enterprise LLC.
- Recipient:
- NYWP Enterprise LLC.
United States
- Issuing Office:
- Philadelphia District Office
United States
| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT Telephone: 215-597-4390 |
Department of Health and Human Services
- 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.
- 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.