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WARNING LETTER

Create-A-Pack Foods, Inc. MARCS-CMS 532708 —


Delivery Method:
UPS

Recipient:
Recipient Name
Glenn M. Cochrane
Create-A-Pack Foods, Inc.

W1344 Industrial Drive

Ixonia, WI 53036-9486
United States

Issuing Office:
Minneapolis District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
 

 

November 2, 2017
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                                        Refer to CMS 532708
 
 
Glenn M. Cochrane
Owner/President
Create-A-Pack Foods, Inc.
W1344 Industrial Drive
Ixonia, Wisconsin 53036-9486
 
Dear Mr. Cochrane:
 
From January 23 to April 20, 2017, the U.S. Food and Drug Administration (FDA or we) conducted an inspection of your facility located at W1344 Industrial Drive, Ixonia, Wisconsin. During this inspection our investigators found violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplement regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(g)(1), in that they have been prepared, packed, or held under insanitary conditions that do not meet CGMP regulations for dietary supplements. 
 
In addition, we reviewed the product labels for your dietary supplements. Based on our review of the labels, we conclude that your (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Intensive Cleansing Blend and (b)(4) Herbal Cleanse Precleansing Blend products violate section 403 of the Act, 21 U.S.C. § 343, and regulations implementing the food labeling requirements of the Act, which are found in 21 CFR 101.
 
You can find the Act and FDA regulations on the internet through links on the FDA’s web page at www.fda.gov.
 
Adulterated dietary supplements
 
Your (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Intensive Cleansing Blend and (b)(4) Herbal Cleanse Precleansing Blend products are adulterated under section 402(g)(1) of the Act, 21 U.S.C. § 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements (21 CFR 111).  The following significant violations of the CGMP requirements were observed during the inspection of your facility:
 
1.    Your quality control personnel did not reject or approve a treatment, in-process adjustment, or reprocessing of a component for which the component’s specification under 21 CFR 111.70(b)(3) was not met, as required by 21 CFR 111.77(a) and 21 CFR 111.113(b)(2).  In accordance with 21 CFR 111.113(b)(2), when a specification established in accordance with 21 CFR 111.70(b)(3) is not met, quality control personnel must reject the component unless such personnel approves a treatment, an in-process adjustment, or reprocessing, as permitted under 21 CFR 111.77. Specifically, your firm used the ingredient burdock root extract that exceeded your microbiological specifications in the manufacture of your (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Herbal Cleanse Intensive Cleansing Blend Dietary Supplement products. 
 
Further, your quality control personnel failed to reject a component that did not meet your identity specifications established under 21 CFR 111.70(b)(1), as required by 21 CFR 111.77(b).  Specifically, your firm used the ingredient nettle leaf extract lot (b)(4) in the manufacture of your (b)(4) Herbal Cleanse Precleansing Blend Dietary Supplement and (b)(4) Herbal Cleanse Intensive Cleansing Blend Dietary Supplement products, but the ingredient did not meet its established component specification for identity.  Your firm had identity testing conducted on the ingredient on two occasions using the test method listed in your component specifications, and both analyses determined that the component was (b)(4) nettle leaf.  Despite your failure to meet the identity specification for the component, you used the component in finished product, which was then shipped and released into commerce.
 
We acknowledge your response to this observation in your letter dated May 10, 2017, however, we are unable to evaluate the adequacy of your corrective actions. The response states that you have lot traceability from your supplier for the component, and the lots of nettle leaf extract were tested and found to be positive for “active ingredient.”  You did not, however, provide information to support that testing for an unnamed “active ingredient” provides identity confirmation for the component. Further, your response did not address the issue of preventing the release of components that are not within specifications for use in the manufacture of dietary supplements.  We will evaluate the adequacy of your corrective actions at our next inspection.
 
2.    Your quality control personnel failed to comply with 21 CFR 111.123(b)(1) because they approved and released for distribution any batch of dietary supplement for which any component in the batch did not meet its identity specification. Specifically, your firm released into distribution (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Herbal Cleanse Intensive Cleansing Blend products, for which the nettle leaf extract lot (b)(4) was found to not meet its identity specification because testing of the component on two separate occasions found the component to be “(b)(4)” of nettle leaf.
 
We acknowledge your response of May 10, 2017, in which you state that you will review the finished product specifications in-depth.  We are unable to evaluate the adequacy of your corrective actions, however, because you have not addressed the issue of preventing the release of any batch of dietary supplements for which the component in the batch does not meet identity specifications.  We will evaluate the adequacy of your corrective actions at our next inspection.
 
3.    Your firm failed to confirm the identity of other components (not including dietary ingredients) and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2).  Specifically, you accepted green tea flavoring for use as a non-dietary ingredient in dietary supplements based on review of your supplier’s COA for the ingredient.  However, you have not qualified the supplier of the ingredient.  Before you rely on a COA from the supplier of a component, you must first qualify the supplier by establishing the reliability of the supplier’s COA through confirmation of the results of the supplier’s tests in accordance with 21 CFR 111.75(a)(2)(ii)(A).  You must further maintain documentation of how you qualified the supplier, and periodically reconfirm the supplier’s COA, 21 CFR 111.75(a)(2)(ii)(C).  Your quality control personnel must review and approve the qualification and re-qualification of the supplier, 21 CFR 111.75(a)(2)(ii)(E).  The supplier’s COA must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations in accordance with 21 CFR 111.75(a)(2)(ii)(B).
 
We acknowledge your response to this observation in the letter dated May 10, 2017. You provided copies of your supplier’s COA and third-party laboratory test results as evidence of testing and examination of the ingredient.  However, we are unable to evaluate the adequacy of your corrective actions because you did not provide documentation showing that you have qualified your supplier or the supplier’s COA, and the third party laboratory COA does not include identity testing.  We will evaluate the adequacy of your corrective actions at our next inspection.
 
Misbranded dietary supplements
 
During the inspection management explained that your firm is responsible for the Supplement Facts information on the labels of the dietary supplement products you manufacture, (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Intensive Cleansing Blend and (b)(4) Herbal Cleanse Precleansing Blend.  Our review of the labels collected during the inspection reveal that the products are misbranded foods under section 403 of the Act because the labels for these products do not comply with the labeling requirements in 21 CFR 101, as follows:
 
1.    The (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Herbal Cleanse Intensive Cleansing Blend products you manufacture are misbranded within the meaning of section 403(q)(5)(F) of the Act, 21 U.S.C. §343(q)(5)(F), in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36.  Specifically:
 
A.   The Precleansing Blend bottle label declares zero values for total fat, sodium, and protein, and the Intensive Cleansing Blend bottle label declares zero values for total fat, sodium, fiber, and protein, and 1% of the Daily Value for calcium, which can also be listed as zero.  The box label also lists these values.  These ingredients are “(b)(2)” dietary ingredients; that is, they are ingredients listed in 21 CFR 101.36(b)(2).  Any “(b)(2)” dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), must not be declared, in accordance with 21 CFR 101.36(b)(2)(i);
 
B.   The heading “%DV†” and the footnote “† Daily Value not established” are not in accordance with 21 CFR 101.36(b)(2)(iii).
 
2.    The (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Herbal Cleanse Intensive Cleansing Blend products you manufacture are misbranded within the meaning of section 403(q)(1)(A) and (B) of the Act, 21 U.S.C. § 343(q)(1)(A) and (B), in that:
 
A.   The bottle labels fail to list the serving size in common or usual household measure, i.e., one bottle, 21 CFR 101.9(b);
 
B.   The box label fails to list the number of servings per container (box) of each of the dietary supplement components contained within 21 CFR 101.9(b) and 101.36(b)(1)(ii).
 
3.    The (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Herbal Cleanse Intensive Cleansing Blend products you manufacture are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that the product labels fail to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4(h).  Specifically:
 
A.   The products contain extracts of burdock root, milk thistle seed, nettle leaf, and Uva ursi leaf, but the product labels fail to state that the ingredients are extracts;
 
B.   The products contain milk thistle seed extract, but the labels for the products list “milk thistle (leaf);”
 
C.   The products contain the herb Urtica dioica, which is declared on the labels as nettle.  The Standardized Common Name for this ingredient is stinging nettle, according to the Herbs of Commerce.
 
4.    The (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Intensive Cleansing Blend products you manufacture are misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because each product label bears or contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact.
 
For example, the (b)(4) Precleansing bottled product label indicates potassium sorbate and sodium benzoate, but “preservatives” only describes one ingredient, i.e., sodium benzoate resulting in the label not being in accordance with 21 CFR 101.22(j).  Likewise, the (b)(4) Intensive Cleansing bottle product contains potassium sorbate and sodium benzoate, but the label fails to identify these ingredients as preservatives.  Finally, the identical Supplement Facts labels from the (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Intensive Cleansing Blend bottled products are replicated on the (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit label.  As a result, the boxed kit product is also not labeled in accordance with 21 CFR 101.22(j).
 
5.    The (b)(4) Herbal Cleanse Precleansing Blend and (b)(4) Herbal Cleanse Intensive Cleansing Blend bottled products you manufacture are misbranded within the meaning of section 403(y) of the Act, 21 U.S.C. § 343(y), in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
 
6.    The (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled component (b)(4) Herbal Cleanse Intensive Cleansing Blend products you manufacture are misbranded within the meaning of section 403(s)(2)(C) of the Act, 21 U.S.C. § 343(s)(2)(C), because each product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).  In particular, the plant part is not indicated for green tea.
 
The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm is in compliance with all requirements of the Act and all federal implementing regulations. 
 
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur.  Failure to promptly correct these violations may result in enforcement action by the FDA without further notice, including seizure and/or injunction.
 
In addition, we offer the following comments: 
  • We note that your specifications for (b)(4) Precleansing Blend list magnesium chelate as an ingredient when it is not used in the product, and fail to list magnesium lactate as an ingredient, even though it is used in the product;
  • “Maganese” is incorrectly spelled on the Supplement Facts labels for the three products (b)(4) Herbal Cleanse 5 Day Cleaning Program Dietary Supplement boxed kit and its bottled components (b)(4) Herbal Cleanse Intensive Cleansing Blend and (b)(4) Herbal Cleanse Precleansing Blend.
You should respond to this office in writing within 15 working days of receiving this letter. In your response you should identify the procedures you have taken or will take to correct the current violations and prevent their recurrence.  You should provide documentation of your corrective actions. If corrective actions cannot be completed within 15 working days of receiving this letter, you should state the reason for the delay and the time frame within which the corrections will be completed. 
 
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, 21 U.S.C. § 379j-31(a)(2)(B).  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 written response should be sent to Boun M. Xiong, Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976.
 
Sincerely,
/S/
Michael Dutcher, DVM
Director, Division 1 West
Office of Human and Animal Food Operations