Inspections, Compliance, Enforcement, and Criminal Investigations
Knott's Wholesale Foods, Inc. 7/15/10
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 37217-1003
July 15, 2010
WARNING LETTER NO. 2010-NOL-16
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Jerry L. Knott, President
Knott's Wholesale Foods, Inc.
125 North Blakemore Street
Paris, Tennessee 38242-4283
Dear Mr. Knott:
On March 9 and 10, 2010, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, located at 125 North Blakemore Street, Paris, Tennessee. During the inspection, labels of your "Pickled Eggs" product were collected. After careful review of your product labels, we found your "Pickled Eggs" product to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (Title 21, United States Code, 342 (USC § 342) and misbranded under Section 403 of the Act (21 USC § 343). Regulations regarding labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
Additionally, this inspection revealed your "Pickled Eggs" product is an acidified food product. As a manufacturer of an acidified food product, you are required to comply with the Act and the federal regulations relating to the processing of acidified food products. These regulations are found in 21 CFR 108, Emergency Permit Control, and 21 CFR 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 USC § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108, Subpart B, including registration and filing of process information, and the mandatory requirements in 21 CFR 114. In addition, based on certain criteria in 21 CFR 114, acidified foods may be adulterated under Section 402(a)(4)of the Act (21 USC 342(a)(4)) if they have been 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. For your reference, the Act, the Emergency Permit Control, Acidified Food, and Labeling regulations can be located through links on FDA's Internet homepage at www.fda.gov.
Your significant violations were as follows:
1. Your "Pickled Eggs" product is misbranded within the meaning of Section 403(q)(1) of the Act (21 USC § 343(q)(1)) because the label fails to bear nutrition information as required by 21 CFR 101.9 and your firm is not currently exempt from the nutrition labeling requirements under Section 403(q)(5)(D) of the Act (21 USC § 343(q)(5)(D)).
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/
SmallBusinessNutritionLabelingExemption/default.htm] for information on filing for an annual exemption. The application may be submitted online at: https://info1.cfsan.fda.gov/nle/client/login.cfm.
2. Your "Pickled Eggs" are also adulterated within the meaning of Section 402(a)(4) of the Act (21 USC § 342(a)(4)) because your firm failed to provide to FDA, not later than 60 days after registration and prior to the packing of a new product, information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, to comply with 21 CFR 108.25(c)(2). Specifically, you have manufactured the acidified product, "Pickled Eggs", and did not file a scheduled process with FDA for this product for each container size. This is a repeat deviation from previous inspections.
Scheduled process information for acidified foods must be submitted on Form FDA 2541 a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods" available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm
This letter is not intended to be a comprehensive list of deficiencies at your facility. It is your responsibility to ensure your facility operates in compliance with the Act and all applicable federal regulations.
You should take prompt action to correct these violations, and you should establish procedures to ensure such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
We also offer the following comment:
If the citric acid, salt, sodium benzoate, and potassium sorbate are present in more than an insignificant amount in the "Pickled Eggs" product, they need to be listed as part of the ingredient statement for the "Pickled Eggs" product. If the sodium benzoate and/or potassium sorbate are functioning as preservatives in the finished product, their function needs to be included in accordance with the requirements of Section 403(k) of the Act and 21 CFR 101.22(j).
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as copies of labeling, forms submitted to FDA, and other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 219-8818,
H. Tyler Thornburg
New Orleans District