Dixie Mills, LLC 3/22/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Atlanta District Office 60 Eighth Street N.E. Atlanta, GA 30309 Telephone: 404-253·1161 FAX: 404-253-1202

MARCH 22, 2011

VIA OVERNIGHT MAIL

Darrell L. Donald, Owner
Dixie Mills, LLC
130 2nd Street W
Tifton, GA 31794-4366

WARNING LETTER
(11 - ATL - 05)

Dear Mr. Donald:

On January 13-19, 2011, the U. S. Food and Drug Administration (FDA) inspected your food manufacturing facility located at 130 2nd Street West in Tifton, GA. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for food found in Title 21 of the Code of Federal Regulations (CFR) Part 110, including significant evidence of rodent and insect activity throughout the plant. These violations render the food products manufactured in your facility adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 342(a)(4)], in that the products were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links on FDA's homepage at www.fda.gov.

Further, two finished product samples were collected for filth analysis during the inspection. Laboratory evaluation confirmed the presence of 213 dead insects (135 adult and 78 larvae) in the finished product sample of Dixie Mills Old Fashioned Yellow Grits coded "Best By May 1011." The presence of insects in this finished product causes the product to be adulterated within the meaning of Section 402(a)(3) of the Act [21 USC § 342(a)(3)], because it consists in whole or in part of a filthy, putrid, or decomposed substance, or it is otherwise unfit for food. We acknowledge that you disposed of the lot of Dixie Mills Old Fashioned Yellow Grits product from which the samples were collected; however, we have no evidence that you have taken any additional action to identify any other potentially adulterated products or to prevent recurrence in the future.

Our investigators issued you a form FDA 483, Inspectional Observations, at the conclusion of the inspection which included, but was not limited to, the significant violations below.

1. You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).

Specifically, investigators observed:
 

• Insects too numerous to count (TNTC) in a pallet containing (b)(4) cases of 12 - 20 oz. bags of Dixie Mills Old Fashioned Yellow Grits stored in the finished product warehouse/held for sale area. The insects were observed on top of the cases, stuck around tape on the cases, inside the cases on product packaging, and inside product packaging of yellow grits;

• Two apparent rodent urine stains on the top layer of a pallet containing (b)(4) cases of 12 - 20 oz. bags of Dixie Mills Old Fashioned Yellow Grits stored in the finished product warehouse/held for sale area;

• Old and fresh rodent excreta pellets TNTC around the walls, along wall beams, under shelving, and under and on pallets of old packaging and damaged product in the warehouse;

• Old and fresh rodent excreta pellets TNTC inside bagging equipment, on bagging conveyor belts, under tables and machinery, and along the walls of the bagging room;

• Old and fresh rodent excreta pellets TNTC and bird droppings on bags of raw ingredients, and along the floor in the ingredient staging area; and

• Rodent excreta pellets TNTC in the corners and under equipment throughout the plant, including in the (b)(4) cleaning room, 1st floor regular grind room, 1st floor fine grind room, and 2nd floor regular grind room.

In addition, our investigators reviewed your pest control log book and found that evidence of rodent activity was repeatedly found and identified in service reports following the pest control technician's biweekly visits. However, there was no evidence of corrective actions initiated by your firm in response to the pest control technician's findings.

2. Failure to maintain buildings and physical facilities in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Specifically, investigators observed:

 

• Peeling paint, which could fall into product while being manufactured, on equipment and west walls in the bagging room;

• Two holes, revealing daylight, in the ceiling on the northwest side of the warehouse; and

• Evidence of water leaks in the warehouse along the ridge vent structure, the northwest corner and at the gutter in the center walk-way, and water stains on the west wall in the bagging room.

We acknowledge that your firm initiated efforts prior to the close of the inspection to correct some of the objectionable observations noted. For example, on 1/18/11, our investigators observed
that litter, waste, and plant foliage that had been observed in various locations outside the facility had been removed. They observed that the majority of old product buildup, dust, cobwebs, and
other debris had been removed from various areas throughout the plant. The rodent excreta pellets and bird droppings had also been removed. As stated above, we are aware that the previously mentioned pallets of Dixie Mills Old Fashioned Yellow Grits were diverted for use as animal feed or otherwise removed from the facility. Although these corrective actions addressed in part some of the immediate violations observed during the inspection, we have not received a response from you outlining the procedures you have taken or intend to take to determine the underlying causes of the violations noted and to prevent their recurrence or the occurrence of additional violations. Failure to take actions to promptly and adequately correct all of these violations may result in FDA initiation of regulatory actions including, but not limited to, seizure or injunction.

This letter is not intended to be an all-inclusive list of the violations that exist at your facility or in your products. You are responsible for ensuring that your firm is operating in compliance with all requirements of the Act and pertinent FDA regulations,such as the CGMP regulations.

Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent any similar ones. For example, identify your procedures for preventing, detecting, and eliminating any further insect or rodent activity and infestation, in addition to procedures for making permanent repairs to your buildings and equipment. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will assist us in evaluating whether any corrections have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the correction(s).

Your written response should be sent to the U. S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. Morton at 404-253-1285 or write to her at the noted address.

Sincerely,
/S/
John Gridley
District Director
Atlanta District Office

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