Inspections, Compliance, Enforcement, and Criminal Investigations
K & D Produce, Inc. 18-Jan-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
January 18, 2006
William K. Chapman, President
K & D Produce, Inc.
1937 West Tennessee Street
Tallahassee, FL 32304-3226
Dear Mr. Chapman:
The Food and Drug Administration conducted an inspection of your firm located at the above address on November 3, 4 and 7, 2005 . The inspection found that you did not follow food Good Manufacturing Practice (GMP) regulations, Title 21, Code of Federal Regulations (21 CFR) Part 110. At the conclusion of the inspection, you were issued a Form FDA-483, which delineated a number of gross insanitary conditions present in your facility at the time of that inspection. We have determined that these conditions cause the products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Food, Drug, and Cosmetic Act (the Act), in that they 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 can also find links to the Act on FDA's website at www.fda.gov.
The following is a list of the insanitary conditions observed by our investigator during the inspection:
1. Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces. Specifically, food contact surfaces of the cutting board, knives, and other processing equipment and utensils were not properly sanitized prior to manufacturing ready to eat coleslaw. [21 CFR 110.35(a)]
2. Failure to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests. Specifically, live flies were observed in the processing area during operations. [21 CFR 110.35(c)]
3. Failure to provide adequate screening or other protection against pests. There is a gap approximately one inch around the processing room door which leads to the outside. This condition allows pests such as insects and rodents to access the facility and adulterate your raw materials and finished products . [21 C.F.R. 110.20(b)(7)]
The above violations are not meant to be an all-inclusive list of deficiencies in your facility . It is your responsibility to assure that all of your products are in compliance with the Act and applicable regulations . You should take prompt action to correct the violations observed during FDA's most recent inspection. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should include each step that has been taken to completely correct the current violations and to prevent the recurrence of similar violations, the time within which correction will be completed, and any documentation necessary to show that correction has been achieved. If you cannot complete all necessary corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 3275 . If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763.
Emma R . Singleton
Director, Florida District