Inspections, Compliance, Enforcement, and Criminal Investigations
Great & Best Co., Inc. 19-May-05
Department of Health and Human Services
Public Health Service
New Orleans District
May 19, 2005
WARNING LETTER NO. 2005-NOL-22
Mr. Steven Lin, President
Great & Best Co., Inc.
2438 Augusta Street
Kenner, Louisiana 70062
Dear Mr. Lin:
On February 14-16, 23, and 25, 2005, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your food storage warehouse and repacking facility, located at 2438 Augusta Street, Kenner, Louisiana. The inspection was conducted to determine compliance with FDA's Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR), Part 110. The criteria and definitions in Part 110 apply in determining whether a food is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. During the inspection, our investigators documented numerous insanitary conditions demonstrating the ingredients and finished food products packed, and/or held at your facility are adulterated within the meaning of Section 402(a)(4) of the Act. You can find the Act through links in FDA's homepage at www.fda.gov.
Among the deviations from 21 CFR 110 were the following:
In order to comply with 21 CFR 110.35(c) you must exclude pests from any area of a food plant. However, the investigator documented rodent activity, including a dead rodent and rodent excreta pellets, in your dry goods warehouse and in coolers 300 and 400. Further, the investigators observed live birds and collected bird excreta in your dry goods warehouse. Finally, the investigators observed insect activity, including live insects and insect casings, in your dry goods warehouse and freezer. Our FDA laboratory confirmed the findings of rodent and bird excreta pellets, bird urine stains, rodent hair, and empty fly pupae in samples taken from your facility during the inspection. Flies and rodents are known vectors of disease organisms.
You must properly store equipment and assure the construction of the plant is suitable to conduct sanitary operations, to comply with 21 CFR 110.20(a)(1) and (b)(1). However, the investigator observed structural defects in your facility permit the entry of pests: open doors to the facility, and large cracks where the walls join the floor. In addition, there were weeds and unused equipment outside the facility which provide harborage for pests
The ceilings, floors and walls in your facility must be constructed in such a manner where as the drip or condensate from fixtures, ducts and pipes does not contaminate food or food packaging materials, in order to comply with 21 CFR 110.20(b)(4). However, in your facility the investigator documented:
Four water leaks from the ceiling into the dry goods warehouse, one which steadily dripped from the ceiling directly onto rice product;
Condensation from the cooling unit dripped directly onto fresh green peppers and fresh green onions stored beneath it; and,
Clogged floor drains and standing pools of water in coolers [redacted] and,[redacted]
You must store toxic cleaning, sanitizing compounds and pesticide chemicals in such a way to protect against contamination of food or food packaging material in order to comply with 21 CFR 110.20(b)(4), However, our investigator observed:
Floor cleanser barrel stored adjacent to cases of fresh garlic;
Cases of bleach stored adjacent to cases of dry noodles;
Case of oranges stored on top cases of bleach;
Chafing dish fuel stored adjacent to bamboo skewers and place mats;
Rodenticide bait pellets spilled on floors of both warehouses, [redacted] coolers, and the freezer. Pallets of fresh produce in pools of water containing dissolving bait pellets; and,
A drum of black oily liquid labeled as poisonous waste stored in dry goods warehouse alongside container of cases of dry noodles.
You should clean non-food contact surfaces as frequently as necessary to protect against contamination of food, in order to comply with 21 CFR 110.35(c)(3). However, our investigator observed:
Spillage from open and damaged products, filth, and garbage in multiple areas of the dry goods warehouse and cooler 300;
Heavy accumulation of litter, waste, spoiled and damaged produce in coolers;
Black, slime substances on bottom of plastic air curtains separating both cooler [redacted] dock area and repacking room/freezer area, and on all four walls and floors of both coolers; and,
Fresh produce was stored on pallets against the walls and in cases on the floor.
The above violations are not meant to be an all-inclusive list as other deficiencies may exist at your facility. It is your responsibility to assure your facility is operated in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction
We are aware during the inspection you made some corrections and promised to put other corrections in place. However, please respond, in writing, within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, you must explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.
H. Tyler Thornburg
New Orleans District