| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human ServicesDecember 20, 2010
Warning Letter NYK-2011-11
VIA U.P.S.
Enid B. Stettner, President and Owner
Wild Thymes Farm Inc.
643 County Route # 403
Greenville, New York 12083
Dear Ms. Stettner:
Between July 7 and 23, 2010, the U. S. Food and Drug Administration (FDA) inspected your manufacturing facility, Wild Thymes Farm Inc. located at 643 County Route # 403, Greenville, New York. The inspection revealed that you have serious deviations from the Acidified Food regulations [21 Code of Federal Regulations (CFR) Parts 108 and 114]. Failure to comply with all of the requirements of 21 CFR 108.25 and the mandatory portions of part 114 constitutes a prima facie basis for the immediate application of the emergency permit control provisions of Section 404 of the Federal Food, Drug and Cosmetic Act (the Act). In addition, such failure renders your Acidified Food adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. Accordingly your firm's acidified food product Indonesian Peanut Sesame Dipping Sauce has been packed or held under insanitary conditions whereby it may have been rendered injurious to health. Additionally, your Wild Thymes Indonesian Peanut Sesame Dipping Sauce, (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce, and Wild Thymes Mango Papaya Chutney products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and the Acidified Food and Food Labeling regulations through links in FDA's home page at http://www.fda.gov.
Acidified Food Adulteration
The significant violations for the acidified food you manufacture include, but are not limited to the following:
1) Your firm did not comply with 21 CFR 108.25(c)(3)(i) in that you did not process each food in conformity with at least the scheduled process filed under paragraph (c)(2) of this section.
• Your scheduled process for Roasted Peanut Sesame Dipping Sauce (b)(4) requires a fill temperature of (b)(4) degrees Fahrenheit (F). Our assessment of your records from July 2007 through the current inspection reveal six of twenty-four records document a fill temperature below (b)(4) degrees F, and nine of twenty-four records fail to document any fill temperatures.
• Your processing authority's procedure specifies a kettle/cook temperature of at least (b)(4) degrees F. Twelve of twenty-four production records dated from August 14, 2007 to June 3, 2010 fail to indicate whether kettle temperature of (b)(4) degrees F was reached.
• No cold spot determination has been made for the Indonesian Peanut Sesame Dipping Sauce manufactured from August 14, 2007 to June 3, 2010 to assure the entire batch reached (b)(4) degrees F in the kettle. Our Investigator was informed your steam kettles are regularly filled above the heating element on the kettles.
2) Your firm made several changes to the manufacturing process for Roasted Peanut Sesame Dipping Sauce (b)(4), including use of several ingredients that were different from the ingredients listed in the recipe filed with the scheduled process; and modification of container closure procedures. However, your firm did not provide this information to FDA as required by 21 CFR 108.25(c)(2) in the form of a revised scheduled process. At the time of the inspection, the most recent scheduled process on file for Roasted Peanut Sesame Dipping Sauce (b)(4) lists the use of the following recipe: 'Fresh Onion, Fresh Ginger, Fresh Garlic, Fresh Jalapeno Peppers and Sesame Oil'. The current recipe being used as of May 22, 2008 no longer uses 'Fresh Onion or Fresh Garlic' but rather uses 'Chopped Dried Onion and Chopped Dried Garlic', additional 'Cider Vinegar' and additional water. From May 22, 2008 to June 3, 2010, the volume of water being used has been changed a second time. The recipe being used from August 14, 2007 to June 3, 2010 has never listed use of 'Sesame Oil', 'Fresh Jalapeno Peppers' or 'Fresh Ginger'. The recipe lists use of 'Canola/Sesame Oil', 'Jalapenos Frozen', and 'Ginger, Frozen'. At the time of the inspection, the scheduled process on file for Roasted Peanut Sesame Dipping Sauce (b)(4) lists use of a (b)(4) for container closure. The investigator observed that the (b)(4) did not function adequately and containers were being hand tightened without any inversion. In addition, you stated to the investigator that you did not think it was possible to invert the bottles after hand tightening the caps. All changes to the filed thermal process must be submitted to FDA on a new filing form (2541a) in accordance with 21 CFR 108.25(c)(2). Containers either must be inverted after filling or be subjected to any acceptable method for applying heat to the lid in order to kill any residual pathogens.
Scheduled process information for acidified or low"acid canned 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/
3) Sufficient control, including frequent testing and recording of results is required by 21 CFR 114.80(a)(2), so that the finished equilibrium pH values for acidified foods are not higher than 4.6. However, your firm tested only one bottle per batch of Indonesian Peanut Sesame Dipping Sauce for finished equilibrium pH. The minimum batch size manufactured from August 14, 2007 to June 3, 2010 contained (b)(4) bottles. The average batch size contained (b)(4) bottles. We recommend that you test at least one bottle at the start, middle and end of each batch.
4) In order to comply with 21 CFR 110.40(1), instruments and controls used for monitoring, regulating or recording temperatures and pH or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained and adequate in number for their designated uses. However, instruments that your firm uses to measure conditions that control or prevent the growth of undesirable microorganisms are not adequately maintained. Specifically, the (b)(4) Thermometer, (b)(4) mercury and glass thermometer, (b)(4) digital thermometer and (b)(4) Infrared thermometer have never been calibrated or sent out for calibration, and all of these devices are a minimum of two years past calibration due dates. Also, the refrigerator used to store product ingredients at your firm lacks any thermometer or temperature measuring/recording device.
5) Your firm did not fully reprocess, thermally process as a low-acid food under 21 CFR 114, or set aside for further evaluation as to any potential public health significance, a portion of food which deviated from your scheduled processes as required by 21 CFR 114.89. Specifically, your scheduled process requires a minimum temperature of (b)(4) degrees F at fill and a maximum equilibrium pH of (b)(4).
• On August 27, 2009, the Indonesian Peanut Sesame Dipping Sauce was filled below (b)(4) degrees F and the batch was released without any regard to the process deviation. The record was not reviewed by the Supervisor trained at Better Process Control School until six months later.
• On December 18, 2009, the Indonesian Peanut Sesame Dipping Sauce was filled below (b)(4) degrees F. The equilibrium pH was not recorded. The batch was released without any regard to the process deviation.
• On May 20, 2009, the Indonesian Peanut Sesame Dipping Sauce was manufactured and no fill temperatures were recorded. The batch was released without any regard to the process deviation.
• On October 23, 2008 and April 14, 2009, the Indonesian Peanut Sesame Dipping Sauce was filled below (b)(4) degrees F. There is no verification the cooking kettle reached (b)(4) degrees F. The batches were released without any regard to process deviations.
• On August 14 and 19, 2008, the Indonesian Peanut Sesame Dipping Sauce was filled below (b)(4) degrees F and released without any regard to process deviations.
• On October 30, 2007, the Indonesian Peanut Sesame Dipping Sauce had a pH of (b)(4) and the batch was released without any regard of the need to evaluate this as a process deviation in accordance with 21 CFR 114.89 (pH above filed scheduled maximum value of (b)(4).
6) Your firm did not examine containers often enough to ensure that containers suitably protect the food from leakage and contamination as required by 21 CFR 114.80(a)(4). After caps are hand tightened, no additional examination or testing is done to ensure proper container closure occurs.
7) You do not have personnel involved in acidification, pH control, heat treatment and critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the FDA commissioner as required by 21 CFR 108.25(f). Specifically, you have no personnel at your firm during processing that have attended and completed an FDA approved Better Process Control School. Specifically, you are the only person who has completed Better Process Control School for acidified foods, and were not present or routinely accessible during processing, packing operations or container closing. Records documenting manufacture are not always reviewed before release of product. Process deviations indicating potential significant health risk were not recognized during your record review.
8) Departures from a scheduled process having a possible bearing on public health or the safety of a food are not noted, identified, recorded, and made the subject of a separate file (or log identifying the appropriate data) delineating them. As required by 21 CFR 114.100(c), you did not have any deviation logbook or any other type of record to identify or address process deviations. Manufacturing records for Indonesian Peanut Sesame Dipping Sauce contained process deviations, which were not recognized or documented.
9) Your firm did not ensure that each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, and the year, date, and period during which it was packed, as required by 21 CFR 114.80(b). Specifically, containers of Indonesian Peanut Sesame Dipping Sauce were not marked with an identifying code.
Food Misbranding
In addition during the inspection, the Wild Thymes Indonesian Peanut Sesame Dipping Sauce, (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce and Wild Thymes Mango Papaya Chutney product labels were collected. After careful review, we find that your products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. The significant violations for the labeling of these products include, but are not limited to, the following:
10) Your Wild Thymes Indonesian Peanut Sesame Dipping Sauce, (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce, and Wild Thymes Mango Papaya Chutney are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] because the Nutrition Facts information does not comply with the requirements in 21 CFR 101.9. Specifically:
• The serving size in the Nutrition Wild Thymes Indonesian Peanut Sesame Dipping Sauce and (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce labels is not declared in accordance with 21 CFR 101.9(b)(2)(iii). The serving size for non-discrete bulk products shall be the amount in household measure that most closely approximates the reference amount for the product category. The Reference Amount Customarily Consumed (RACC) for sauces for dipping is 2 tbsp. (21 CFR 101.12(b), Table 2). Therefore, the serving size should be declared as "2 tbsp. (30 mL)." Your labels incorrectly list the serving size as "1 Tbsp(15g)." The nutrition values and servings per container information provided in the labeling of your products must be based on this serving size.
• Your Wild Thymes Mango Papaya Chutney and (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce labels do not declare servings per container as required by 21 CFR 101.9(d)(3)(ii).
11) Your Wild Thymes Indonesian Peanut Sesame Dipping Sauce, (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce and Wild Thymes Mango Papaya Chutney products are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product labels fail to bear adequate common or usual names of each ingredient from which they are fabricated. For example:
• Your Wild Thymes Indonesian Peanut Sesame Dipping Sauce and (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce products are fabricated from two or more ingredients and each ingredient is not declared on the label as required by 21 CFR 101.4 as follows:
o Your (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce ingredient statement does not include canola oil, dextrose, partially hydrogenated rapeseed oil, partially hydrogenated cottonseed oil, and partially hydrogenated soybean oil, all of which are contained in this product according to your production records.
o Your Wild Thymes Indonesian Peanut Sesame Dipping Sauce ingredient statement does not include dextrose, partially hydrogenated rapeseed oil, partially hydrogenated cottonseed oil, and partially hydrogenated soybean oil, all of which are contained in this product according to your production records.
The dextrose, partially hydrogenated rapeseed oil, partially hydrogenated cottonseed oil, and partially hydrogenated soybean oil are component ingredients of the Crunchy Peanut Butter used in the manufacture of your (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce and Wild Thymes Indonesian Peanut Sesame Dipping Sauce. 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 multicomponent 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)].
• Your Wild Thymes Indonesian Peanut Sesame Dipping Sauce (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce and Wild Thymes Mango Payaya Chutney labels fail to declare paprika and/or turmeric as "spice and coloring" unless these spices are declared by their common or usual names as required by 21 CFR 101.22(a)(2). Specifically:
o Your Wild Thymes Indonesian Peanut Sesame Dipping Sauce and (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce is made with (b)(4) Curry which contains the sub-ingredients paprika and turmeric according to your formulation sheet. However the product labels only declare "SPICES."
o Your Wild Thymes Mango Papaya Chutney contains paprika according to your formulation sheet. However, the product label only declares "SPICES."
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations (specifically 21 CFR Parts 101, 110, and 114). You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
We also have the following comments about your product labels:
• On your Wild Thymes Indonesian Peanut Sesame Dipping Sauce and (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce product labels the quantitative amounts for the following nutrients are not rounded in accordance with the requirements of 21 CFR 101.9(c): Calories, Fat Calories, Total Fat, Sodium, Vitamin A, Vitamin C and Iron.
• The ingredients statements on Wild Thymes Indonesian Peanut Sesame Dipping Sauce and (b)(4) Indonesian Peanut Sesame Premium Dipping Sauce product labels read "fresh roasted peanuts," however according to your production records, your products are made with manufacturer peanut butter not fresh peanuts that you have roasted. Therefore your product does not contain "fresh roasted" peanuts. In addition, the word "fresh" is intervening material. Title 21 CFR 101.2(e) states that all required information appearing on the information panel shall appear in one place without intervening material.
• On your Wild Thymes Mango Papaya Chutney product label the quantitative amounts for the following nutrients are not rounded in accordance with the requirements of 21 CFR 101.9(c): Fat Calories, Carbohydrates, Dietary Fiber, Sugars, Protein, Vitamin A and Vitamin C.
• On your Wild Thymes Mango Papaya Chutney product label the quantitative amounts for many of the nutrients in the nutrition label are rounded to the nearest tenth decimal place. Title 21 CFR 101.9(c) requires rounding to whole numbers with the exception of fats (Total Fat, Saturated Fat, Trans Fat, Mono- and Polyunsaturated Fats) which may be rounded to the nears 0.5 gram increment below 5 grams.
You should notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term corrective action, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or Email at dean.rugnetta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
cc:
Alfred Stettner, Ann Stettner, and Ryan J. Schroeder
Wild Thymes Farm Inc.
643 County Route # 403
Greenville, New York 12083
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