|Company:||Gordon Food Company, Inc.|
|Subject:||CGMP for Foods/Adulterated|
|Issuer:||Nashville District Office|
|Issued:||June 20, 2012||Closed:||
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
June 20, 2012
WARNING LETTER NO. 2012-NOL-24
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Michael J. Gordon, President
Gordon Food Company, Inc.
160 Cumberland Street
Memphis, Tennessee 38112-3820
Dear Mr. Gordon:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your multiple food storage facility, located at 160 Cumberland Street, Memphis, Tennessee, from February 21-23 and March 1, 2012. During the inspection, FDA investigators documented serious violations of Title 21, Code of Federal Regulations, Part 110 (21 CFR 110), Current Good Manufacturing Practice regulations. The inspection revealed the condition of food storage areas caused the food to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United State Code (USC) 342(a)(4)] because the food had been held under insanitary conditions whereby it may have become contaminated with filth. Our lab confirmed rodent evidence collected from various products and storage areas in your warehouse. You can find the Act and the regulations through links on 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)]. Three dead rodents were observed on glue traps along the wall, as well as, beside and behind pallets of chocolate products being stored in what you refer to as the "chocolate room." Rodent excreta pellets were observed along all walls in the chocolate room, as well as on pallets used to store food products in this room. Approximately eight of twenty-one pallets holding chocolate and pasta products stored in the chocolate room contained what appeared to be rodent gnawed holes penetrating through to food products. Sample 583011, containing cuttings for these rodent gnawed holes, was collected by our investigators and analysis of this sample by the FDA Southeast Regional Laboratory confirmed rodent incisor marks on the subsamples of product containers.
2. Failure to provide adequate screening or other protection against pests [21 CFR 110.20(b)(7)]. Exterior doors were observed to be open throughout the day on February 21-23, 2012, during the inspection.
3. Failure to store food under conditions to protect against contamination by condensate falling from pipes leading from the cooling unit in your firm's freezer storage area [21 CFR 110.93 and 110.20(b)(4)]. On February 21, 2012, condensate was dripping directly onto food products stored in the freezer.
4. Failure to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food [21 CFR 110.37(f)]. On February 21, 2012, left over product and debris, such as damaged food products, blankets, and scrap material, were observed stored along the south wall of the main warehouse.
The violations cited in this letter may not be all inclusive of violations that 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.
We are aware you made a verbal commitment to correct many of the observed deficiencies during the inspection. We received your March 27, 2012, response to the FORM FDA 483. FDA acknowledges the corrective actions you accomplished during the inspection with regard to cleaning and the voluntary destruction of $750.63 worth of various food products and your plans to renovate the facility. 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, and complete the planned building renovations.
Deviations noted in this letter are the same or similar to those deviations noted during the previous FDA inspection of your firm. 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. We may take further regulatory action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating.
Section 743 of the Act (21 USC Parts 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including costs related tore-inspection. Are-inspection is one or more inspections conducted subsequent to an inspection which is identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees, 21 USC Parts 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related tore-inspection.
Please respond to Kari L. Batey, Compliance Officer, Food and Drug Administration, at the above address. Ariy questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.
Patricia K. Schafer
New Orleans District
Enclosure: FORM FDA 483 dated March 1, 2012