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  5. Dutch Kettle (The) - 04/15/2016
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WARNING LETTER

Dutch Kettle (The) Apr 15, 2016

Dutch Kettle (The) - 04/15/2016


Recipient:
Dutch Kettle (The)


United States

Issuing Office:
Atlanta District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Atlanta District Office
60 8th Street NE
Atlanta, GA 30309 

 

April 15, 2016
 
 
VIA UPS
RETURN RECEIPT REQUESTED
 
Mr. Stephen V. Peachey, Owner
The Dutch Kettle
5016 Hunting Creek Church Road
Hamptonville, NC 27020 – 7750
 
WARNING LETTER
(16-ATL-09)
 
Dear Mr. Peachey:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified food manufacturing facility located at 5016 Hunting Creek Church Road in Hamptonville, North Carolina on August 13-17, 2015. The inspection revealed serious violations of the regulations for acidified foods found at Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control, and Part 114, Acidified Foods (21 CFR Parts 108 and 114). As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.
 
We have determined that your acidified food products are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that 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.You can find the Act and the acidified food regulations through links on FDA’s home page at www.fda.gov.
 
You were issued a FORM FDA 483, Inspectional Observations, at the close of our establishment inspection. To date, our office has not received a written response from you to address our concerns as indicated on that FORM FDA 483. Your significant violations are as follows:
 
1.    A commercial processor, when first engaging in the processing of acidified foods shall not later than 60 days after registration, and before packing of any new product, provide the FDA information on the scheduled processes including, as necessary, 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 Part 108.25(c)(2). 
 
Specifically, your firm failed to file scheduled processes with FDA for your Sugar Free (No Sugar Added) Sweet Potato Butter and your Sugar Free (No Sugar Added) Pumpkin Butter prior to manufacturing these products. Additionally, you indicated during the inspection that you filed a scheduled process for your firm’s Pumpkin Butter product; however, a check of FDA’s online database during the inspection did not show that a scheduled process had been filed for this product.   
 
Furthermore, with respect to the following products, your processing records do not show the monitoring of the cook time and temperature. 
 
a)    Lot # 4308B of Sugar Free (No Sugar Added) Sweet Potato Butter was manufactured on 11/4/2014. You did not file a scheduled process with FDA for this product. The associated processing authority letter indicates that a thermal processing time of (b)(4) minutes at (b)(4) is required, however.
b)    Lot # 4338 and Lot # 5022B of Pumpkin Butter was manufactured on 12/4/2014, and 1/22/2015, respectively. There is no record that you filed a scheduled process with FDA for this product. The associated processing authority letter indicates that a thermal processing time of (b)(4) minute at (b)(4) is required, however.
c)    Lot # 4267B and Lot # 5113B of Sugar Free (No Sugar Added) Pumpkin Butter was manufactured on 9/17/2014, and 4/23/2015, respectively. You did not file a scheduled process with FDA for this product. The associated processing authority letter indicates that a thermal processing time of (b)(4) minutes at (b)(4) is required, however.  
 
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic) either electronically or by paper submission. Publications addressing both methods of filing can be found at: 
 
For additional information on the types of products FDA considers to be acidified foods, please refer to the 2010 Draft Acidified Food Guidance Document at the following link: 
 
We acknowledge that a check of FDA’s online database on 9/30/2015 revealed that as of 9/3/2015, you filed the scheduled processes with FDA for your Sugar Free Sweet Potato Butter and your Sugar Free Pumpkin Butter. 
 
2.    Instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms must be accurate and adequately maintained to comply with 21 CFR Part 110.40(f). Specifically, you do not calibrate the thermometers you use to record the fill temperatures for your products.
 
3.    Your Dutch Kettle No Sugar Added Blackberry Jam product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the label bears a nutrient content claim, but the product does not meet the requirements to bear the claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirement pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. 
 
Specifically, the label for the Blackberry Jam product bears the claim “No Sugar Added.” The use of this term or similar terms are allowed if the product does not contain an ingredient containing added sugars such as jam, jelly or concentrated fruit juice per 21 CFR 101.60(c)(2)(ii). However, the second ingredient for this product is declared as “white grape conc.” and the label, as well as your website, states “sweetened only with pure fruit juices.” We further note that “white grape conc.” should be listed as “white grape juice concentrate.”
 
We also offer the following comments: 
  • We note that the statement of the place of business does not include a street address for your Blackberry Jam and Apple Butter products. The street address may only be omitted if it is shown in a current city directory or telephone directory as required by 21 CFR 101.5(d).
  • The “May contain artificial coloring” statement on your Homemade Style Apple Butter product is not declared in accordance with 21 CFR 101.4.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility. It is your responsibility to ensure that the products you manufacture are in compliance with all requirements of the Act and pertinent FDA regulations, such as the emergency permit, acidified food, and general food GMP regulations (21 CFR Parts 108, 114, and 110). You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov. You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement sustainable corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice. 
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. Please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address. 
 
Sincerely,
/S/ 
Ingrid A. Zambrana
District Director
Atlanta Office