Inspections, Compliance, Enforcement, and Criminal Investigations
New Rich City Co. 7/3/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
July 3, 2012
Ms. Xiaoping Sun, President/Owner
New Rich City Company
2560 N. American Street
Philadelphia, PA 19133-3412
Dear Ms. Sun:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your multiple food warehouse, located at 2560 N. American Street, Philadelphia, PA, on June 4 through June 8, 2012. During the inspection, FDA investigators documented significant violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the food products stored and processed 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth.
In addition, sub-samples of food items, stained and gnawed packaging stored at your facility are adulterated within the meaning of Section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3), in that they consisted in part of a filthy substance by reason of the presence of rodent excreta, rodent urine stains and rodent gnaw holes through intact packaging. You can find the Act and the FDA regulations through links in FDA’s homepage at www.fda.gov.
Your significant violations are as follows:
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 observed the following evidence of a lack of pest control:
a. Rodent Excreta Pellets (REPs):
i. Rodent excreta pellets (REPs), too numerous to count, were observed on pallets of gnawed bags of (b)(4) Rice in the south west corner of the storage area.
ii. Five (5) REPs were observed on bags of (b)(4) White Rice, located in the south west corner, and in front of the back exterior loading door of your facility.
iii. REPs, too numerous to count, were observed on, under and next to a pallet of (b)(4) Medium Weight plastic spoons, located in the north section of the storage room.
iv. One (1) REP was observed on a box of (b)(4) Rice Flour, located on a pallet along the east west wall of the storage area.
b. Rodent Urine Stains:
i. Rodent urine stains were observed on multiple 50 lb bags of (b)(4) White Rice, located on a pallet in the south west corner, and in the front of the back loading door leading to the outside of your facility.
ii. Rodent were observed on all 20 lb bags of (b)(4) Bread Crumbs, located in the middle of the east wall of the storage area, and close to the main entrance of your facility.
iii. Rodent urine stains were observed on all 25 lb bags of Extra Fine Cracker Meal, located in the middle of the east side of your facility.
iv. Rodent urine stains were observed of two (2) 40 lb bags of Tempura Batter Mix, and 10 (25 kg) bags of (b)(4) Potato Starch, located in the middle of the west side of your facility, and along the inner wall bordering the walk-in refrigerators.
c. Live Insects:
i. Flies too numerous to count, were observed in direct contact with whole raw onions stored in mesh bags, located in the south east section along the wall opposite the main entrance of your facility.
ii. A fly was observed on top of a bucket of (b)(4) Soy Sauce, located in the south east corner and to the left of the main entrance.
iii. Insect webbing was observed on products including (b)(4) Bread Crumbs, located midway along the east wall of the storage area near the main entrance. Also, insect webbing was observed along the eastern and western walls and south west corner of your facility.
iv. Two (2) live unidentified insects were observed on a bag of Extra Fine Cracker meal, located in the middle of the east side of the storage area.
d. Dead Insects:
i. Dead cockroaches and other insects were observed on a glue board along the eastern wall to the right of the main entrance of your facility.
e. Avian Excreta:
i. Avian excreta were observed on top of a case of (b)(4) Vinegar, located in the center of the east side of the storage area of your facility.
ii. Avian excreta were observed on three (3) bottles of (b)(4) Cooking Sherry, located in the center of the east side of the storage area of your facility.
f. Live Animals:
i. During the inspection, two guard dogs were observed traveling freely throughout your facility where food is stored.
ii. During the inspection, two cats were observed traveling freely throughout your facility where food is stored.
g. Animal Excreta/Urine:
i. During the inspection, fresh and dried apparent dog excreta were observed throughout your facility; in between and behind pallets of food located in the storage area along the inner wall bordering the walk-in refrigerators. Additionally, animal excreta were observed in the standing water located next to the inner wall bordering the walk-in refrigerators.
ii. Apparent fresh cat excreta was observed directly on top of a bag of (b)(4) the (b)(4) Rice, and urine like stains on seven (7) bags of the same product stored in your available stock, located in the south west corner of the storage area.
iii. A cardboard box being used as a litter box containing fresh animal excreta, was observed under a pallet rack holding food products, located in the south west corner of the storage area by the entrance of a walk in refrigerator.
h. Animal Food:
i. During the inspection, cat food was observed on a metal dish stored on top of boxes containing Foam Hinged Lid Containers, located in the south east corner of your facility near the office.
i. Animal Hair:
i. During the inspection, apparent animal hairs were observed on cans of Szechuen Preserved Vegetable Shredded, located in the center of the east side of the storage area.
ii. Apparent animal hairs were observed on a bag of (b)(4) Potato Starch, located in the south east section of your facility along the wall opposite to the main entrance.
2. As required by 21 CFR 110.35(a), you must maintain buildings, fixtures and other physical facilities in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated. However, our investigator observed the following during the inspection:
a. Two rooms adjacent to the storage area where the guard dogs were kept, were observed to contain equipment and debris laden with rodent excreta, and had a stench of animal excreta and/or decomposing material.
b. A hole was observed with loose insulation in the wall located next to the loading door in the southwest corner of your facility.
c. Pallets of various foods and packages of food product containers were stacked directly against the wall and next to each other prohibiting the examination of the products and/or cleaning of your facility.
d. A gap of approximately ½ inch was observed between the floor and the exterior loading door, located in the northwest corner of your facility.
e. A gap of approximately ½ inch was observed between the floor and the bottom corners of the exterior loading door, located in the southwest corner of your facility.
f. A hole of approximately, ½ x 3 inches was observed at floor level along the south exterior wall of your facility.
g. The loading door serving as the main entrance to the facility was observed to be left open throughout the duration of the inspection.
3. You must properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding: place, or harborage for pests, to comply with 21 CFR 110.20(a)(1). However, our investigator observed the following objectionable conditions:
a. Weeds and overgrown plants were observed along the exterior north, east, south and west walls of your facility. Furthermore, overgrown plants were observed directly in front of the two loading doors located in the rear of the building along the west wall of your facility.
b. Discarded equipment and debris were observed against all four exterior walls of the food storage warehouse.
c. Weeds and grass approximately 4 feet tall were observed growing on the grounds within 15 feet from the building.
4. You failed to properly store finished food under conditions that will protect against physical contamination, as well as against deterioration of the food and container, as required by 21 CFR 110.93: Specifically, our investigators observed:
a. Whole raw onions stored loose on flattened cardboard boxes lay directly on the warehouse floor, and some onions were directly on the floor located in the northeast side of the warehouse.
b. Numerous expired, leaking, swollen and/or dented canned products stored with your available stock located along the east side of the storage area.
i. Water Chestnuts, coded (b)(4)
ii. Wei-Chuan Bamboo Shoots, coded as (b)(4)
iii. Szechuen Preserved Vegetable Shredded, best before 09/09/2010
iv. Kari-Out Panda Honey Blend lot (b)(4)
c. Standing water on the floor behind at least six pallets storing various food products, located in the middle of the west side of the storage area along the inner wall bordering the walk-in refrigerators.
d. Standing water on the floor and in close proximity to the ice machine, located in the northwest area of the facility and in the north refrigerated walk-in room.
e. Employees standing directly on top of boxes containing (b)(4) Bamboo Shoots, in the southwest corner of your facility.
f. Numerous foot prints were observed on product packing including:
i. A bag (b)(4) Bread Crumbs, located in the center of the eastern side of the facility.
ii. A box of (b)(4) Almond Cookies located in the southwest corner of the facility.
g. Food debris was observed under a large number of pallets throughout the facility.
h. Pallets were observed to be stacked directly on top of food products.
The violations cited in this letter may not be all inclusive of violations that exist in connection with your products and/or facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.
We are aware you made a verbal commitment to correct many of the observed deficiencies during the inspection, and we acknowledge the corrective actions you accomplished during the inspection with regard to cleaning and the voluntary destruction of food products. However, you are requested to notify this office in writing within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to prevent the recurrence of violations, or similar violations. Deviations noted in this letter are the same or similar to those deviations noted during previous FDA inspections of your firm.
In your response, include documentation such as certification of actions performed by a licensed exterminator, other actions performed to control unauthorized entrance of pests, plans on how you intend to protect food products from possible contamination, and/or any other useful information that would assist us in evaluating your corrections. If additional planned corrections will occur over time, please include timeframe for implementation of those corrections. If you cannot complete· all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations. We may take further regulatory action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating.
Section 743 of the Act (21 USC Parts 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)). 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Please send your reply to the United States Food and Drug Administration, United States Customhouse, Room 900, 2nd & Chestnut Streets, Philadelphia, PA 19106, Attention: Robin M. Rivers, Compliance Officer. If you have any questions regarding any issue in this letter, please do not hesitate to contact Ms. Rivers at (215)717-3076.
Kirk D. Sooter
Philadelphia District Office