| Public Health Service Food and Drug Administration |
| Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771 |
Department of Health and Human Services
WARNING LETTER
CIN-10-64234-20
August 13, 2010
VIA UNITED PARCEL SERVICE
Mr. John R. Troyer
President
Amish Wedding Foods, Inc.
316 S. Mad Anthony St.
Millersburg, OH 44654-1388
Dear Mr. Troyer:
The U.S. Food and Drug Administration (FDA) conducted two inspections of your manufacturing facility located at 316 S. Mad Anthony St., Millersburg, Ohio, on April 15, 16, and 21 and May 7, 11, and 12 of 2010. The inspections disclosed that you manufacture low-acid foods, namely Sweet Potato Butter and Pumpkin Butter.
We found that you have serious deviations from the low-acid food regulations. As a manufacturer of low-acid food products, you are required to comply with the Federal Food, Drug and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid food products. These regulations are described in Title 21, Code of Federal Regulations, Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113); 21 CFR 108, Subpart B (21 CFR 108.35), Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit; and 21 CFR 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
Failure to comply with all of the requirements of 21 CFR 108.35 and the mandatory portions of Parts 113 constitutes a prima facia basis for the immediate application of the emergency permit control provisions of Section 404 of the Act. In addition, such failure renders your low-acid food adulterated within the meaning of Section 402(a)(4) of the Act [21 United States Code (USC) § 342(a)(4)]. Accordingly, your variously labeled sweet potato butters and variously labeled pumpkin butters are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the low-acid food regulations through links in FDA's Internet home page at http://www.fda.gov.
Per 21 CFR 113.3(n), low-acid foods are identified as having a pH greater than 4.6 and a water activity greater than 0.85. Hermetically sealed low-acid foods must achieve and maintain a finished, equilibrium pH value of 4.6 or lower and a water activity of 0.85 or lower in order to prevent the growth of pathogenic microorganisms, as required by 21 CFR 110.80(b)(4). Your low acid foods, as evidenced below, did not achieve and maintain, throughout the product shelf-life, the necessary pH value at or below 4.6 and water activity at or below 0.85.
During the inspection in April 2010, our investigators collected, and FDA analyzed a sample of Sweet Potato Butter, lot 01061237, and a sample of Pumpkin Butter, lot 00781239, to determine pH value and water activity level. Lab results for the Sweet Potato Butter, sample 515781, had pH values range from 4.69 to 4.88 and water activity levels range from 0.928 to 0.94. Lab results for the Pumpkin Butter, sample 515782, had pH values range from 4.58 to 4.84 and water activity levels range from 0.945 to 0.971. Lab analysis results are enclosed for both samples.
At the conclusion of the May 2010 inspection, the FDA investigator discussed with your firm the observation noted on the Form FDA-483, Inspectional Observations, issued to your firm. Your significant violation was as follows:
1. As a commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers, you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimal initial temperatures, times and temperatures of processing, sterilization value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process for each low-acid food in each container size, to comply with 21 CFR 108.35(c)(2). However, your firm has not filed scheduled processes with FDA for low-acid food products you manufacture, namely Pumpkin Butter and Sweet Potato Butter.
Scheduled process information for low-acid foods must be submitted on Form FDA 2541a (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.
Scheduled processes must be established by qualified persons having expert knowledge acquired through appropriate training and experience in the thermal processing of low-acid foods in hermetically sealed containers, as required by 21 CFR 113.83.
In addition, during the May 2010 Inspection, product labels for your Amish Wedding Old Fashioned Sweet Potato Butter, Pumpkin Butter and Amish Cheese House Old Fashioned Pumpkin Butter were collected. After careful review of your product labels, we find that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] as follows:
2. Your Amish Wedding Old Fashioned "Sweet Potato Butter", "Pumpkin Butter" and Amish Cheese House Old Fashioned "Pumpkin Butter" are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4 as follows:
• Based on information provided during the inspection, your Amish Wedding Old Fashioned Sweet Potato Butter has salt as an ingredient; however, you fail to list it on your finished product label.
• Based on information provided during the inspection, your Amish Wedding Old Fashioned Pumpkin Butter has water, salt and brown sugar as ingredients; however you fail to list those ingredients on your finished product label. In addition, your product label declares lemon juice as an ingredient, but based on information provided during the inspection lemon juice is not an ingredient. If lemon juice is not an ingredient in this product, it should not be declared in the ingredient statement.
• The product label for your Amish Cheese House Pumpkin Butter lists "lemon juice or citric acid" as ingredients; however your product formulation for this product does not include the use of lemon juice or citric acid in its manufacture. Additionally, you can not use "or" in your ingredient statement. The ingredient statement should be an accurate list of only the ingredients that are used in the product's manufacture. In addition, based on information provided during the inspection, water, salt and brown sugar are ingredients in your pumpkin butter product; however you fail to list those ingredients on your finished product label.
The requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
3. Your Amish Wedding Old Fashioned "Sweet Potato Butter", "Pumpkin Butter" and Amish Cheese House Old Fashioned "Pumpkin Butter" products are further misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343 (e)(2)] because the labels fail to bear the net quantity of contents in accordance with 21 CFR 101.105. The term "net weight" should be used when stating the net quantity of contents in term of weight [21 CFR 101.105(j)(3)]. Additionally, the net weight for your 18 oz. products should be declared in pounds and ounces followed by the metric equivalent in parenthesis [21 CFR 101.105(j)(1); 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. Several of your products declare the metric equivalent in "mL"; however grams are the appropriate metric unit of measure for weight.
4. Your Amish Cheese House "Old Fashioned Pumpkin Butter" is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts panel fails to list all the required nutrients as defined by 21 CFR 101.9(c). Specifically, your product label does not declare Calories from Fat and Vitamins and Minerals [21 CFR 101.9(c)(1)(ii) and 101.9(c)(8)(iii)].
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure; injunction and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
As president, it is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. For instance, in addition to implementing a voluntary recall of all lots of pumpkin and sweet potato butter, your management stated that you would cease production of these products until you consulted with a process authority and filed scheduled processes. Your response should address any corrective actions you have implemented based on your discussions with a process authority. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be sent to Ms. Allison C. Hunter, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, you may contact Ms. Hunter at (513) 679-2700, ext. 134, or you may forward a facsimile to her at (513) 679-2773.
Sincerely,
/S/
Teresa C. Thompson
Director
Cincinnati District
No comments:
Post a Comment