Inspections, Compliance, Enforcement, and Criminal Investigations
Mermentau Rice, Inc. 18-Jan-02
DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
January l8, 2002
WARNING LETTER NO. 2002-NOL-20
Mr. Robert A. Hanks, CEO
Mermentau Rice, Inc.
215 East Pinhook Road
Lafayette, Louisiana 70501
Dear Mr. Hanks:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 102 South 13th Street, Mermentau, Louisiana, on December 5-11, 2001. During the inspection, the investigators documented numerous insanitary conditions that cause the rice products you manufacture to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). They are adulterated because they have been prepared, packed or held under conditions whereby they may become contaminated with filth.
The inspection found that you have not taken effective measures to exclude pests from the processing and storage areas and to protect against the contamination of food on the premises by pests. Failure to exclude pests is a potential contributing factor to microbiological contamination. The following was observed:
- Dead and decaying rodents were observed in the processing area above the finished bulk rice packing area, in spilled rice on the ground one foot from a shelling machine, and in spilled rice on the ground six feet from a shelling machine;
- Rodent gnawed bags of finished rice product and bale wrappings were observed in the finished product storage area;
- At least 239 rodent excreta pellets were observed throughout the finished product storage area;
- At least 400 rodent excreta pellets were observed along the walls of the rough rice, small bin storage building;
- At least 50 rodent excreta pellets were observed in approximately 100 pounds of spilled, in-process rice on the rail dock on the north exterior wall of the finished product storage area;
- At least 200 rodent excreta pellets were observed on the south side of the rail dock;
- At least 250 live flies were observed on rice hulls located on the ground outside of the facility on the south side. Also, flies were observed in areas immediately adjacent to the iron steps leading to the finished product storage area and adjacent to an unscreened opening to the milling building;
- Live flies were observed on a broken sewer cover and on the ground adjacent to the open
sewer holding tank; and,
- Numerous flies were observed on in-process rice throughout the facility.
Our investigator documented the construction and design of your facility facilitates unsanitary operations. For example:
- All dock doors of the milling plant, finished product storage area, and bulk package loading area were not equipped with pest restraining devices;
- A ? to ? inch gap in a 12 foot section of the joint between the wall and floor in the finished product storage area leads directly to the outdoor environment;
- The cover to the sewer holding tank on the west side of the mill was broken exposing sewage contents of the tank to the outdoor environment; and,
- Oil was observed leaking from the compressed air pipe onto the floor in the milling area near processing equipment.
You have not disposed of raw materials and other ingredients in a manner that protects it against becoming an attractant and a harborage or breeding place for pests:
- Spilled rice was observed on the floor throughout the processing area and storage areas of the facility; and,
- Spilled rice was observed on top of covers to the storage bins and the covers of the finished rice conveyers.
You have not properly stored equipment or removed litter and waste within the immediate vicinity of the plant building that may constitute an attractant, breeding place, or harborage for pests. For example:
- Wood, equipment, and parts of machinery were stored on the floor in the southeast comer and the west wall of the finished product storage area;
- Bolts, screws, and other small ancillary equipment were observed on top of milling equipment; and,
- Discarded products, damaged products, finished products, and raw material bag stock are stored in the finished product storage area.
You have not maintained the parking lot so that it will not constitute a source of contamination in areas where food is exposed. Large pools of dirty stagnant water were observed adjacent to the rough rice storage area.
Toxic compounds were not stored in a manner that protects against contamination of the food. A can of oil was observed on top of a shelling machine and another container of oil was observed on the floor in the milling building.
These findings are further detailed in the enclosed Form FDA 483. We are aware that you
promised to correct some of the deviations listed on that form.
The above cited violations are not intended to be an all-inclusive list of deficiencies that may exist with your products at your facility. It is your responsibility to ensure that all of your operations are in compliance with applicable Federal requirements.
We strongly recommend you determine the cause(s) of the rodent infestation and take corrective action as soon as possible. Failure to implement lasting corrective action may result in regulatory action being initiated by FDA without further notice. This action may include product seizure and/or injunction against you and your company.
We request that you notify this office in writing within 15 working days of receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. Include in your correspondence an explanation of each step being taken to prevent future recurrence of similar violations and copies of any available documentation demonstrating that corrections have been made.
Your response should be directed to Mark W. Rivero, Compliance Officer, at the above address.
Patricia K. Schafer
Acting District Direct0 P
New Orleans District