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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Phoenix Enterprises, L.L.C. 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) 779-5454
FAX: (410) 779-5707

FEI: 3003615143

03-BLT-12

March 27, 2003
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Peter Chan, Co-owner
Phoenix Enterprises, L.L.C.
1266 5th Street, N.E.
Washington, D.C. 20002

Mr. Gerard Chan, Co-owner
Phoenix Enterprises, L.L.C.
1266 5th Street, N.E.
Washington, D.C. 20002

Dear Mr. Chan:

The Food and Drug Administration (FDA) conducted an inspection of your food warehousing facility located at 1266 5th Street, N.E., Washington, D.C., on January 28-31, February 3-7, February 10-14, and February 17-21, 2003. The inspection revealed numerous deviations from the Current Good Manufacturing Practice in Manufacturing Packing, or Holding Human Food, 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 described the insanitary conditions in your facility 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 Food, Drug, and Cosmetic Act (the Act).

The conditions observed included:

  • A live rodent was observed in the "middle" storeroom on the [redacted] floor of building [redacted]
  • Apparent rodent gnawed product containers [redacted] were observed in food storage areas on the first floor of building [redacted].
  • Apparent rodent excreta pellets and rodents nesting material was observed in food and office storage areas throughout buildings [redacted] and [redacted]
  • Apparent rodent excreta pellets were observed in boxes containing food products [redacted]
  • A live bird was observed in building [redacted] pecking through a product container and consuming the product ([redacted]) inside.
  • Products were stored in cluttered fashion throughout all warehouse storage areas.
  • Exterior structural defects were observed in several locations (gaps above and below doors, windows with missing glass/ covering, and holes in walls) affording entryways and harborage for pests. In addition, doors were left open, affording entryways for pests.
  • Interior structural defects were observed in several locations throughout building [redacted] and [redacted] (holes .in floors and walls, gaps between the wall and floor, gap under elevator shaft door, non-functioning sump pumps with no coverings, and floor drain with inadequate cover) that afford entryways and harborage for pests.
  • Dust, dirt, debris, and flaking paint on the ceiling and above food products were observed in building [redacted].
  • Leaking fluid was observed dripping on boxes containing canned food and paper/Styrofoam food packaging materials.
  • There were no safety-type light bulbs or fixtures in any of the food storage areas.

You should take prompt action to correct these deviations. Failure to do so may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.

Please notify this office 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. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be sent to the- Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland, 21215, to the attention of Vinetta Howard-King, Compliance Officer. Ms. Howard-King can be reached at (410) 779-5454, extension 413.

Sincerely,

/s/

Lee Bowers

Director, Baltimore District