Inspections, Compliance, Enforcement, and Criminal Investigations
Mid South Produce Distributors, LLC 4/13/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
April 13, 2010
WARNING LETTER NO. 2010-NOL-13
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Joseph C. Spears, Co-Owner & President
Joseph A. Spears, Co-Owner
Mid South Produce Distributors, LLC
1215 Baptist World Center Drive
Nashville, Tennessee 37207-5329
Dear Messrs. Spears:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing and storage facility, located at 1215 Baptist World Center Drive, Nashville, Tennessee, from February 8, 2010 to February 19,2010. During the inspection, FDA investigators documented serious violations of Title 21, Code a/Federal Regulations, Part 110 (21 CFR 110), Current Good Manufacturing Practice (CGMP) regulations. The inspection revealed the condition of food storage areas caused the food to be adulterated under Section 402(a)(4) [21 United State Code (USC) 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) because the food had been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth. You can find the Act and the regulations through links in FDA's Internet Homepage at www.fda.gov.
The following significant deviations were observed during the inspection:
1. Failure to take effective measures to exclude pests from the food storage areas to protect against the contamination of food [21 CFR 110.35(c)]. Hundreds of rodent pellets, gnawed produce, rodent gnawed holes, and millipedes, were found in the dry storage room, small equipment storage room, lettuce cooler, onion cooler, and on the loading dock.
2. Failure to provide adequate screening or other protection against pests [21 CFR 110.20(b)(7)]. Your facility had broken windows and openings in the roof over the dry storage room, providing pests easy access to food.
The violations cited in this letter may not be all-inclusive of violations which exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of Federal law and FDA regulations. Other federal agencies may take this warning letter into account when considering the award of contracts.
You appear to have taken prompt action to correct the violations cited in this letter. FDA acknowledges the corrective actions you accomplished during the inspection with regard to building renovations, cleaning, and the voluntary destruction of adulterated food products. However, you are requested to notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to prevent the recurrence of violations or similar violations. Please explain and include documentation of any additional corrective action you have taken. If additional planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
Please respond to Kari L. Batey, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483