| Public Health Service Food and Drug Administration |
| Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313·393·8100 FAX: 313·393·8139 |
Department of Health and Human Services
WARNING LETTER
2010-DT-20
September 30, 2010
VIA UPS
Mr. Kai K. Wong, President and CEO
DW Trading, Inc.
3649 Lafayette Road
Indianapolis, Indiana 46222
Dear Mr. Kai:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing and storage facility, located at 3649 Lafayette Road, Indianapolis, Indiana, on May 18, 20-21, and 25-26, 2010. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). The conditions observed during the inspection cause food products processed or stored in your facility to be adulterated under 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 been contaminated with filth or rendered injurious to health. You can find the Act and the regulations through links in FDA’s Internet Homepage at www.fda.gov.
Your significant violations of the CGMPs are as follows:
1. Failure to store finished food under conditions that will protect against physical, chemical, and microbial contamination [21 CFR 110.93]. Specifically, investigators observed rodent excreta pellets on the packaging of finished food products throughout your facility, and a field exam of two separate lots of flour found contamination of both lots by rodent excreta pellets. One of these lots of flour was also found during the field exam to be contaminated by bird-like feathers. Bird droppings, live insects, and dead insects were observed on several bags of flour. Rodent gnaw marks were found on several bags of potato starch. Investigators observed cooler condensate dripping on exposed products including ready-to-eat cabbage. A utensil used to scoop ice onto ready-to-eat vegetables was found lying on a surface contaminated with oil and a black mold-like substance.
2. Failure to maintain your buildings and other physical facilities of your plant in a sanitary condition and in repair sufficient to prevent food from becoming adulterated [21 CFR 110.35 (a)]. Specifically, the roof was found leaking onto a case of mandarin oranges. Furthermore, investigators observed that the exterior of your facility was not maintained in a manner sufficient to prevent pests from entering and contaminating stored and processed foods. Specifically, holes and/or gaps were observed in exterior walls, around exterior fixtures such as air intake louvers, and under person and dock doors. Open pipes and air intake louvers and fans were not screened to prevent pests from entering the building.
3. Failure to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests [21 CFR 110.35(c)]. Specifically, investigators observed a variety of living and dead animals and insects in your facility including a mouse-like animal running through your facility; a bird flying around the facility; and, a number of dead cockroaches on a glue board.
4. Failure to use insecticides or rodenticides under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food packaging materials [21 CFR 110.35(c)]. Specifically, investigators observed poison bait boxes in close proximity to food products in your facility.
5. Failure to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of your facility that may constitute an attractant, breeding place, or harborage for pests [21 CFR 110.20(a(1)]. Specifically, investigators observed mounds of trash and debris, overgrown vegetation, and standing water in the immediate vicinity of your facility. Mechanical debris, equipment, and a number of (b)(4) gallon drums were also observed against the north wall of your facility. These conditions are capable of harboring mammalian and avian pests and insects that may find access to the interior of the facility.
6. Failure to handle and maintain equipment and utensils used to convey, hold, or store food during manufacturing or storage in a manner that protects against contamination [21 CFR 110.80(b)(7)]. Specifically, investigators observed that metal scoops used to repackage foods, such as spices and nuts, were not cleaned between uses and were stored in a manner that exposed them to contaminants.
7. Failure to provide adequate lighting in areas where food is examined, stored, or processed [21 CFR 110.20(b)(5)]. Specifically, eight (8) overhead lights were observed to be non-functioning in the South West area of your warehouse. These conditions provide a desirable area for pests to nest and make it difficult to clean and inspect the area.
8. Failure to maintain plumbing in a manner that will avoid creating an unsanitary condition and that will avoid constituting a source of contamination to food, water supplies, equipment, or utensils [21 CFR 110.37(b)(3)]. Specifically, a urinal in the bathroom on the lower level of the warehouse was overflowing. Persons using the bathroom were forced to track through the standing drainage when entering or leaving.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
FDA notes that during the inspection the Indiana State Department of Health (ISDH) placed an embargo on two lots of contaminated product as follows:
1. (b)(4) bags of (b)(4) Lot (b)(4)
2. (b)(4) bags of (b)(4) All Purpose Flour, Lot (b)(4)
We also acknowledge that immediately following the inspection you voluntarily destroyed these two lots of flour in addition to the following items:
1. (b)(4) bags of (b)(4) Flour, Lot (b)(4)
2. (b)(4) bags of (b)(4) Brand Oriental Style Noodles
3. (b)(4) bags of (b)(4)
3. (b)(4) bags of (b)(4)
4. (b)(4) bags of (b)(4)
During the inspection you indicated your plans to correct the violative conditions noted by investigators and listed in the FDA Form 483 which was issued to you at the conclusion of the inspection. You also indicated that many of your proposed corrective actions would be accomplished within 30 days of receiving the FDA Form 483.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Please include and explain any documentation that supports your corrective actions. If additional planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
Your written response should be sent to Tina M. Pawlowski, Ph.D., Compliance Officer, at the above address. If you have any questions regarding this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by e-mail at tina.pawlowski@fda.hhs.gov.
Sincerely,
/S/
Joann M. Givens
Detroit District Director
Detroit District Office
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