• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Create-A-Pack Foods, Inc. 9/19/12

  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142

 

September 19, 2012
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                          
Refer to MIN 12 – 42
 
 
Glen M. Cochrane
President and Owner
Create-A-Pack Foods, Inc.
W1344 Industrial Drive
Ixonia, Wisconsin 53036-9486
 
Dear Mr. Cochrane:
 
We inspected your facility located at W1344 Industrial Drive, Ixonia, Wisconsin, on March 6-9, 12-16, 19, 21-23, 26-27, 29 and April 5, 12, 2012. The inspection determined that your facility produces thermally processed low-acid foods packaged in hermetically sealed containers, acidified foods, dietary supplements, and 100% juice products. Many of these products are labeled at your firm. We found that you are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) in that you are in violation of Title 21, Code of Federal Regulations (21 CFR): Part 101, Food Labeling regulations; Part 108, Emergency Permit Control regulations; Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulations; Part 114, Acidified Foods Current Good Manufacturing Practice regulations; Part 120, the Juice Hazard Analysis and Critical Control Point (HACCP) regulations; and Part 110, the Current Good Manufacturing Practices regulation for food. The products include (b)(4) Water, (b)(4) liquids, (b)(4) with various flavors, (b)(4) syrup, (b)(4) Concentrate, (b)(4), Cherry Juice concentrates and (b)(4) products.
 
As a manufacturer of thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods, you are required to comply with the Act and the federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers and acidified food products. These regulations are described in 21 CFR Parts 101, 108, 113, and 114. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25 and 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113 and 114. In addition, based upon certain criteria in 21 CFR Parts 113 and 114, thermally processed low-acid foods in hermetically sealed containers and acidified foods may be adulterated within the meaning of section 402(a)(3) of the Act, 21 U.S.C. § 342(a)(3), in that they consist in whole or in part of any filthy, putrid or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health.
 
Our inspection revealed serious violations of FDA’s Juice Hazard Analysis and Critical Control Point (HACCP) regulations, 21 CFR Part 120. These violations cause your 100% juice products to be adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. 
 
Our review of your product labels reveals that your (b)(4) brand (b)(4) products are misbranded within the meaning of section 403, 21 U.S.C § 343, due to violations of FDA’s Food Labeling regulations, 21 CFR Part 101.
 
Furthermore, we have found that your (b)(4) brand (b)(4) is promoted with claims which cause it to be a drug as defined in section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). You can find this Act and the federal regulations through links on FDA’s home page at www.fda.gov.
 
We have received your May 1, 2012, written response to the form FDA-483, Inspectional Observations, issued to your firm on April 12, 2012. Your response was taken into account concerning the significant violations cited in this letter.
 
Emergency Permit Control and Low-Acid Foods
 
The significant violations of 21 CFR Part 108, Emergency Permit Control, and 21 CFR Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, regulations are as follows:
 
  1. Your firm failed to process each thermally processed low-acid food packaged in hermetically sealed containers in conformity with at least the scheduled process as required by 21 CFR 108.35(c)(3)(i). For example, on 3/2/12, you filled (b)(4) Chocolate with temperatures between (b)(4)ºF into pouches; on 2/17/12 you filled (b)(4) Chocolate with temperatures between (b)(4)ºF into pouches; on 3/6/12 you filled (b)(4) Chocolate with temperatures between (b)(4)ºF into pouches; on 2/23/12 you filled (b)(4) Espresso with temperatures between (b)(4)ºF into pouches; and on 2/15/12 you filled (b)(4) Espresso with temperatures between (b)(4)ºF into pouches. Your scheduled processes for these products require a fill and hold time and temperature of (b)(4)ºF for (b)(4). We acknowledge your response indicates that you have submitted revised scheduled processes for these products which better reflect your batch processing and hot-fill operation, and we understand that you are monitoring and recording the fill temperature and the hold time and temperature during the manufacturing of these products. We will evaluate your firm’s adherence to the revised scheduled processes of these products during the next inspection.
  1. Your firm failed to document the recording thermometer readings on the thermal processing records to ensure that the minimum process was met for the manufacture of your (b)(4) and (b)(4) syrup products as required by 21 CFR 113.100(a). For example, you manufactured the following (b)(4) products, but did not record the thermal process: (b)(4) Espresso, lot 12048; (b)(4) Espresso, lot 12017; (b)(4) Chocolate, lot 11325; and (b)(4) Chocolate, lot 12017. Also, you manufactured the following (b)(4) syrup products but did not complete the filler recorder temperature charts: lot 12068; lot 12039; lot 12067; and lot 12040. We acknowledge your firm’s corrective actions in that you have hired an outside service to fix, calibrate, verify and certify your chart recorders, and you have updated your records to include temperature monitoring from handheld devices for comparison. These corrective actions, as well as other record improvements, will be verified during the next inspection.
  1. Your firm failed to maintain records to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use as required by 21 CFR 113.100(d). For example, you transferred lots of (b)(4) Espresso to your fulfillment center on 1/19/12 but did not retain lot traceability of that lot once it reached the fulfillment center. We acknowledge that your response indicates that you are tracking distribution of product to your order fulfillment center and also to the purchasing customers. These records will be verified during the next inspection. 
 
Emergency Permit Control and Acidified Foods
 
The significant violations of 21 CFR Part 108, Emergency Permit Control, and 21 CFR Part 114, Acidified Foods, regulations are as follows:
 
  1. Your firm failed to provide FDA with the process and procedure information deemed necessary to determine the adequacy of the scheduled process as required by 21 CFR 108.25(c)(3)(ii). Specifically, your firm could not provide process information for obtaining commercial sterility of the cap and headspace during filling of your (b)(4) Water, (b)(4) products. At the time of the inspection, your firm’s procedure was to (b)(4). We acknowledge that your response indicates that you have modified your processes for your (b)(4) Water and (b)(4) products to include fill temperatures at a minimum of (b)(4)°F and (b)(4). We will verify your adherence to your current scheduled processes on file, specifically (b)(4), for your (b)(4) Water product (SID (b)(4)) and your (b)(4) varieties during the next inspection. In addition, at this time, there is no scheduled process on file for your (b)(4) Prune Juice product as the latest process (SID (b)(4)) was returned and deleted on April 6, 2012.
  1. Your firm failed to test and examine containers often enough to ensure that the container suitably protects the food from leakage or contamination as required by 21 CFR 114.80(a)(4). For example, you manufactured numerous lots of (b)(4) Water, documenting cap failure with failure rates at times above (b)(4)%. This includes lots 10196, 10197, 10224, 10228, 10278, 10347, 10349, 11003, 11020, 11132, 11144, 11174, 11199, 11201 and 11308. In response to the high failure rate, you (b)(4). However, you continued to have seal failures on your product packaging and you continued to ship the affected product in interstate commerce. We acknowledge that your response indicates that you are currently conducting (b)(4) tests to monitor seal closures and that you have developed the specifications necessary to identify acceptable ranges in values. However, we consider (b)(4) tests inadequate to monitor container integrity and recommend evaluating seal integrity by using pull-up and security tests, which are more commonly used by industry for these types of containers.
  1. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to 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, as required by 21 CFR 108.25(c)(2). However, your firm has failed to file scheduled processes for the following (b)(4) brand acidified food products: (b)(4). We acknowledge that your firm submitted two scheduled processes for (b)(4) brand products (SID (b)(4) and SID (b)(4)); however, these processes were returned on March 28, 2012, and no revised processes have been received at this time.
  1. Your firm failed to maintain records to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use as required by 21 CFR 114.100(d). For example, you transferred lots of (b)(4) acidified food products to your fulfillment center but did not retain lot traceability of those lots once they reached the fulfillment center. Those (b)(4) products include Vanilla, transferred on 1/3/12; Banana, transferred on 2/20/12; Orange, transferred on 1/12/12; Tropical, transferred on 2/18/12; Huckleberry, transferred on 2/21/12; Raspberry, transferred on 2/28/12; and Apple Cinnamon transferred on 3/23/12. We acknowledge that your response indicates that you are tracking distribution of product to your order fulfillment center and also to the purchasing consumers. These records will be verified during the next inspection.
 
Juice HACCP
 
The significant violations of 21 CFR Part 120, Juice Hazard Analysis and Critical Control Point (HACCP) systems, regulations are as follows:
 
  1. Your firm failed to take corrective actions when a deviation from a critical limit occurred during the manufacture of (b)(4) Cherry Juice Concentrate as required by 21 CFR 120.10(a). For example, when you manufactured lot 12039 of (b)(4) Cherry Juice Concentrate in 32 oz. bottles on your (b)(4) heat exchanger and (b)(4) filler the (b)(4) exceeded the (b)(4) in your HACCP plan. You did not document a corrective action for this deviation. Furthermore, you distributed this product in interstate commerce. 
 
Your firm’s response indicates that you have updated your juice HACCP plan in March 2011 to reflect the correct (b)(4) and that you should have documented the corrective actions taken by your firm. You also state in your response that the product was released based on the fact that the incoming juice had already received a 5-log treatment. This part of your response is inadequate as you are required under 21 CFR 120.24(c) to process the product to achieve a 5-log reduction at your facility.
 
  1. Your firm failed to implement your procedures, and to conduct them at the frequency at which they are to be performed, that are used to monitor each of the critical control points (CCPs) listed in your HACCP plan for your 100% cherry juice products as required by 21 CFR 120.8(a). For example, on 4/27/11 and on 5/11/11, you manufactured (b)(4) Cherry Juice Concentrate, only checking the (b)(4) as required under CCP (b)(4) of HACCP plan (b)(4) Also, you are not monitoring the (b)(4) machine to ensure the (b)(4). Your firm’s response states that you will monitor the (b)(4) of process. To ensure an adequate thermal process, we agree you need to revise your protocol to monitor the (b)(4) and that this parameter should be established within the context of a validated HACCP plan.
  1. Your firm failed to validate your HACCP plan for 100% cherry juice products and your HACCP plan for 100% (b)(4) puree products as required by 21 CFR 120.11(b). You do not have documentation to ensure that your processes consistently treat your juice products with a 5-log reduction of public health organisms. Your firm’s response is inadequate because you failed to address the main concern of validating your 5-log reduction for both HACCP plans in order to be in compliance with this requirement of the regulation.
 
Unapproved New Drugs
 
During the inspection at your facility our investigators collected labels associated with many of your products. Based on our review of your product labels, we have determined that the product (b)(4) brand (b)(4) is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your label establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this dietary supplement product with these types of claims violates the Act. 
 
Examples of some of the claims observed on your product labeling include:
 
  • (b)(4): Cranberry has been shown to prevent urinary tract infections…in women.”
 
Such a claim is evidence that the product is intended for use as a drug within the meaning of section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). Consequently, the product is a new drug under section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof. Under section 505(a) of the Act, 21 U.S.C. § 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless it is subject of a FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This product intended for use in humans does not have approved applications and its introduction or delivery for introduction into interstate commerce violates section 301(d) of the Act, 21 U.S.C. § 331(d). Your distribution of this product violates the law. 
 
Misbranding
 
  1. Your (b)(4) brand (b)(4) dietary supplement product is misbranded within the meaning of section 403(i)(2), 21 U.S.C. § 343(i)(2), of the Act in that your label fails to declare completely or accurately all of the ingredients used by your firm in the production of this product in accordance with 21 CFR 101.4(b). For example, the (b)(4) container label lists: “Fruit Pectin***Proprietary Herb Blend: Burdock (root), Milk Thistle (leaf), Nettle (leaf), Uva Ursi (leaf)***Creatine Monohydrate***Other Ingredients: Filtered Water, Fructose, Citric Acid, Natural Flavors, FD&C Yellow #6, FD&C Red #40 & Blue #2, Potassium Sorbate, Sodium Benzoate (as preservatives).” While the (b)(4) carton label lists: “Fruit Pectin***Proprietary Herb Blend: Burdock (root), Milk Thistle (leaf), Nettle (leaf), Uva Ursi (leaf)***Creatine Monohydrate***Other Ingredients: Filtered water, fructose, citric acid, natural flavor, vegetable juice for color, phosphoric acid, potassium sorbate, sodium benzoate.”
  1. Your (b)(4) brand (b)(4) dietary supplement product is misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the product bears or contains artificial coloring. The label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients, 21 CFR 101.22(k). Specifically, your carton label and/or container label declares the ingredients FD&C Yellow No. 6, FD&C Red No. 40, FD&C Blue No. 2 and/or vegetable juice. For example, your product fails to declare the presence of FD&C Yellow No. 6, FD&C Red No. 40, and FD&C Blue No. 2 in the ingredient statement on the outer carton label. Additionally, your product fails to declare the presence of vegetable juice as a color additive on the finished container label.
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
We also note the following labeling observations: 
 
  • The (b)(4) sucrose solution, (b)(4) and (b)(4) brand (b)(4) dietary supplement product labels contain false statements. Specifically, these labels list water as “filtered” and “purified”; however, the water used in the manufacture of these products is not filtered or purified. 
  • The (b)(4) Concentrate product label contains false and misleading statements. For example, the label lists the product as a “concentrate” but it is a single strength puree. Additionally, the label lists the product as “creamed” but the product is not creamed and does not contain cream.
  • The ingredient statement for several varieties of the (b)(4) dietary supplements in bottles and pouches (i.e., Banana, Apple-Cinnamon, Raspberry, etc.) declares “(b)(4) ® (Fruit Juice, Natural Grain Dextrins)” as an ingredient. Based on prior inspections by FDA, (b)(4) consists of grape juice and rice dextrin; however, the label fails to identify these specific sub-ingredients as required by section 21 CFR 101.4(b).
  • The (b)(4) Vanilla product label fails to include a complete domestic address or domestic phone number through which the responsible person, as described in section 761(b), may receive a report of a serious adverse event with such dietary supplement. 
  • Label discrepancies exist between the container and carton label of your (b)(4) brand (b)(4) dietary supplement product. For example, the Amount per Serving values listed in the Supplement Facts panel of the container label are less than what is represented on the carton label. 
  • Your (b)(4) brand (b)(4) contains false or misleading information regarding the presence of cranberry extract in the product. Cranberry or cranberry extract are not declared on either the container or the carton ingredient statements. A review of batch record 11002-001 at the time of inspection does not reveal cranberry or cranberry extract as an ingredient. The only ingredient listed to contain any cranberry derivative is component (b)(4) which is identified as “(b)(4),” not an extract as declared on your finished product labels. If this product does not contain cranberry extract, statements made in the labeling for these products asserting that such product contains cranberry extract are false and misleading. 
 
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. 
 
Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and injunction.
 
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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your reply should be directed to Acting Compliance Officer Marie A. Fadden at the address indicated on the letterhead.
 
                                                         
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District