Inspections, Compliance, Enforcement, and Criminal Investigations
Yarbrough Produce Company 19-Apr-05
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone : 5U4-253-4519
April 19, 2005
WARNING LETTER NO. 2005-NOL-18
Mr. Kenneth F. Yarbrough, Jr., Vice President/Co-Owner
Yarbrough Produce Company, Inc.
624 16"' Avenue West
Birmingham, Alabama 35204
Dear Mr. Yarbrough:
On March 1, 2005, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 624 16th Avenue West, Birmingham, Alabama. During the inspection, copies of your labeling were collected. Review of your labels revealed your firm's cole slaw sold on the retail market are not labeled in compliance with Title 21 of the Code of Federal Regulations, Part 101 (21 CFR 101), Food Labeling, which causes your cole slaw to be misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the CFR through links in FDA's home page at http://www.fda.gov.
Our review of your labels revealed the following:
1. The product, Granny's Cole Slaw, is misbranded within the meaning of Section 403(q)(1) of the Act since the label fails to bear nutrition labeling as required by 21 CFR 101.9 and the product is not exempt from this requirement under Section 403(d)(5) of the Act. This deviation was previously brought to your attention during the inspection of April 19-20, 2004.
We may take further action if you do not promptly correct the violation. For instance, we may seize your products and/or enjoin your firm from operating. We are aware you made a verbal commitment to correct the labeling on your cole slaw product at the close of the inspection.
Please respond in writing within fifteen (15) working days from your receipt of this letter outlining the specific steps you are taking to correct the deviation. You should include in your response any documentation or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
This letter is not intended to be an all-inclusive list of the deviations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and Food Labeling regulations. You also have a direct responsibility to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 253-4519.
Patricia K. Schafer
Acting District Director
New Orleans District