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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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DC Oriental Wholesaler 27-Mar-03

Department of Health and Human ServicesDepartment 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) 779-6464

FAX: (410) 779-5707

03-BLT-11

March 27, 2003

WARNING LETTER

Certified Mail

Return Receipt Requested

Mr. Joseph C. H. Nguyen, Manager

DC Oriental Wholesaler

2030 West Virginia Avenue, N.E.

Washington, D.C. 20002

Dear Mr. Nguyen:

The Food and Drug Administration (FDA) inspected your food storage warehouse located at 2030 West Virginia Avenue, N.E., Washington, D.C. 20002, on January 28 through February 3, 2003. The inspection revealed numerous deviations from the Good Manufacturing Practice (GMP) Regulations, Title 21, Code of Federal Regulations (CFR), Part 110. At the conclusion of the inspection, you were issued a Form FDA 483, Inspectional Observations (copy enclosed), which describes the insanitary conditions observed in your firm during the inspection. These conditions cause the products stored in your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act ("Act").

Effective measures are not being taken to protect against the contamination of food on the premises by pests, in violation of 21 CFR 110.35(c). Specific examples include:

  • Live birds flying in the second floor of the warehouse and perched on top oof cardboard boxes containing [redacted] Noodle
  • A dead bird near the middle of the room on the third floor;
  • An approximate 5 foot x 9 inch build-up of bird excreta on the third floor with more than 100 bird feathers stuck to the bird excreta,
  • Three dead rodents in the southeast corner of the third floor, next to the staircase leading to the second floor;
  • One dead rodent on the second floor under a pallet holding cardboard boxes of [redacted] Oriental Style Noodle located on the second floor,
  • A rodent gnawed hole in a 14 oz cellophane bags containing White Corn [redacted]
  • A rodent gnawed hole in a 5 lb plastic bag containing [redacted] Broken located on the second floor;
  • More than 100 rodent excreta pellets underneath a pallet holding cardboard boxes of dried mushroom [redacted] located on the second floor;
  • More than 100 rodent excreta pellets on the floor in the northeast corner of the second floor
  • More than 25 rodent excreta pellets inside a cardboard box containing 14 oz. Cellophane bags of White Corn [redacted] located on the second floor;
  • More than 25 rodent excreta pellets on top of a cardboard box containing Chinese New Year envelopes and next to cardboard containing [redacted] brand Shrimp Chips stored on the second floor
  • More than 25 excreta pellets on the floor behind a pallet containing cardboard boxes of [redacted] Oyster Sauce stored on the second floor;
  • More than 25 rodent excreta pellets inside a box labeled Plastic Tangerine Tree and next to 19 cardboard boxes containing Dried aniseed stored on the second floor;
  • Eleven rodent excreta pellets on top of a cardboard box containing [redacted] Candy stored on the second floor.

Failure to maintain buildings in repair sufficient to prevent food from becoming adulterated, in violation of 21 CFR 110.35(a). Specifically,

  • Five broken windows were found on the third floor of the warehouse.

You should take prompt action to correct these deviations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and the Good Manufacturing Practice regulations, 21 CFR Part 110. You are responsible for implementing procedures to prevent further violations of the Act and all applicable regulations.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence. Your response should outline the specific things that you are doing to correct these deviations. You should include in your response documentation and written verification procedures or other useful information that would assist us in evaluating your 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 deviations.

Your reply should be sent to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, Attention: Rosalie Bucey, Compliance Officer. Ms. Bucey can be reached at (410) 779-5417.

Sincerely,

/s/

Lee Bowers

Baltimore District Director