• 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

CocoKefir, LLC 11/6/12

  

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

 

November 6, 2012
 
 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                          
Refer to MIN 13 - 07
 
 
Michael R. Larsen
Chief Executive Officer
CocoKefir, LLC
716 Tower Drive
Medina, Minnesota 55340
 
Dear Mr. Larsen:
 
On May 4, 7, 10 and 15, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility located at 716 Tower Drive, Medina, Minnesota. The inspection revealed serious violations of Title 21, Code of Federal Regulations (21 CFR), Part 111, Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, causing your Tula’s CocoKefir, Tula’s Citrus CocoKefir, and Tula’s Apple Cinnamon CocoKefir 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 conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements. 
 
However, this letter should not be interpreted to mean that FDA agrees with the characterization of the products as dietary supplements. In fact, the website for your products at http://www.cocokefir.com uses the following terms to describe the products:  “beverages,” “nature’s sports drink,” and “probiotic drink.” Additionally, the statements of identity for the products state that they are “refreshing” probiotic supplements. All of these statements indicate that the products are represented for use as conventional foods.  Section 201(ff)(2) of the Act, 21 U.S.C. § 321(ff), states, in part, that the term “dietary supplement” means a product that “is not represented for use as a conventional food.” If these products are labeled as dietary supplements, they cannot also be represented for use as conventional foods because a product intended for use as a conventional food is not a dietary supplement. Such labeling would misbrand the products within the meaning of section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1), in that the labeling would be false or misleading. Further, the introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).      
 
You can find the Act and regulations through links on FDA’s homepage at www.fda.gov.
 
The significant violations observed during the inspection include the following:
 
  1. You failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplements that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically, you told our investigators that your firm does not have written master manufacturing records for any of your CocoKefir products.
 
In your response letter dated June 4, 2012, you state that you are “…creating a written master manufacturing record protocol…” with a completion date of June 30, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any master manufacturing records.
 
  1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you told our investigators that your firm has not established product specifications for any of your finished dietary supplement products.
 
In your response letter dated June 4, 2012, you state that you are “…revising and memorializing…finished batch product specifications…” and that these specifications will be fully documented via SOPs by June 30, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any written product specifications.
 
  1. You failed to establish an identity specification and component specifications that are necessary to ensure the specifications for the purity, strength and composition of dietary supplements manufactured using the components, as required by 21 CFR 111.70(b)(l) and (2). In addition, you failed to establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3).
 
In your response letter dated June 4, 2012, you state that your firm “…has now begun documenting its specifications for incoming dietary ingredients and components…via the company’s SOPs” and that these specifications will be completed by June 30, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any written component specifications.
 
  1. You failed to conduct at least one appropriate test or examination before using a component to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i). Specifically, you confirmed to our investigator that no identity testing was conducted on incoming dietary ingredients.  The requirement to verify the identity of any component that is a dietary ingredient applies unless you petition FDA under section 21 CFR 111.75(a)(1)(ii) and FDA exempts you from such testing.
 
In your response letter dated June 4, 2012, you state that your firm is requesting the necessary Certificates of Analysis (COAs) from supplier(s).  However, your response is inadequate because a COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient, 21 CFR 111.75(a).  You are required to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you successfully petition FDA for an exemption from such testing, 21 CFR 111.75(a)(1)(i).
 
  1. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you verbally confirmed to our investigators that you did not have any written quality control procedures in place. You must make and keep the records of the written procedures for the responsibilities of the quality control operations in accordance with subpart P of 21 CFR Part 111, 21 CFR 111.140(b)(1).
 
In your response letter dated June 4, 2012, you state that you are “committed to writing through…Standard Operating Procedures…” a quality management program with a completion date of June 30, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any documentation, e.g., SOPs, of your corrective action.
 
  1. Your batch production records failed to include complete information relating to the production and control of each batch as required by 21 CFR 111.255(b). The batch records that you provided to our investigators at the time of inspection did not include complete information related to production and in-process controls used during production. Specifically, the batch tracking sheet used by your firm to document the production of  your Tula’s CocoKefir, Tula’s Citrus CocoKefir and Tula’s Apple Cinnamon CocoKefir dietary supplements batches were missing the following information:
 
A.   the identity of equipment used during batch production, 21 CFR 111.260(b);
B.   the date and time of maintenance, cleaning and sanitizing of the equipment used during production of the batch, 21 CFR 111.260(c);
C.   the identity and weight or measure of each component used, 21 CFR 111.260(e);
D.   a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, 21 CFR 111.260(f);
E.   the results of any testing or examination performed during the batch production, 21 CFR 111.260(h);
F.   the initials of the person performing each manufacturing step and the person responsible for verifying the weight or measure of each component used in the batch, and for verifying the addition of components to the batch, 21 CFR 111.260(j);
G.   an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record, 21 CFR 111.260(k)(2); and
H.   documentation at the time of performance that quality control personnel reviewed the batch production record, 21 CFR 111.260(l)(1).
 
In your response letter dated June 4, 2012, you state that your “…batch tracking record – and associated procedures – are being revised and updated” and that you have already created and are using records and procedures for the finished product labeling and fermentation vessel cleaning and sanitation. You also state that these actions have a completion date of July 30, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any documentation to determine the effectiveness of your corrective action.
 
  1. You failed to qualify a supplier of a component by establishing the reliability of the supplier’s Certificate of Analysis (COA) through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A).  You verbally confirmed that you did not qualify any of your suppliers or establish the reliability of your suppliers’ Certificate of Analysis. At the time of inspection, you provided our investigator with a COA for Stevioside (b)(4) which is used in all of your products; however, no supplier qualification document was provided as required by 21 CFR 111.75(a)(2)(C). In addition, the Stevioside COA is inadequate because it does not include a description of the test or examination methods used, as required by 21 CFR 111.75(a)(2)(ii)(B). 
 
In your response letter dated June 4, 2012, you state that your firm is “…specifying and implementing appropriate supplier qualification/testing procedures” with a completion date of June 30, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any documentation to determine the effectiveness of your corrective action.
 
  1. You failed to ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(2). In particular, there is insufficient scientific documentation to support the “best by” dating specification applied to finished batches of Tula’s CocoKefir, Tula’s Citrus CocoKefir, and Tula’s Apple Cinnamon CocoKefir dietary supplements. At present, your firm is adding an 8 week shelf life date to all of your dietary supplement products; however, the only product that your firm has any scientific data for is your Tula’s CocoKefir dietary supplement. In addition, your firm only has 6 weeks worth of data for Tula’s CocoKefir dietary supplement instead of the 8 weeks worth of scientific information to support the “best by” date.
 
In your response letter dated June 4, 2012, you state that your firm will be conducting shelf life studies for its products with a qualified laboratory, based on organoleptic and microbiological stability. You stated that these studies will be completed by August 15, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any documentation to determine the effectiveness of your corrective action.   
 
  1. You failed to establish written procedures described under 21 CFR 111.560 relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Your process at the time of our inspection included an “incident report” which you stated was for internal production type issues and not for capturing information from outside sources, i.e., customers.
 
In your response letter dated June 4, 2012, you state that your firm is developing a complaint handling system and that this system will be completed by June 30, 2012. We are unable to assess the adequacy of your corrective action because you have not provided our office with any documentation.
 
  1. Personnel engaged in manufacturing, packaging, labeling, and holding dietary supplements do not have the education, training, or experience to perform their assigned functions, as required by 21 CFR 111.12(c). During the inspection, you informed our investigator that your employees who engage in quality control operations, manufacturing, packaging, labeling, holding, and distribution of finished dietary supplements have never received CGMP training.      
 
In your response letter dated June 4, 2012, you state that your firm is developing an SOP for Quality Control which will be completed by June 30, 2012. Furthermore, you state “all CocoKefir employees will receive Employee Practice GMP training by June 30, 2012.” We are unable to evaluate the adequacy of your response because you have not provided our office with any documentation of your corrective action.
 
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
 
We also note that three of your products, namely Tula’s CocoKefir, Tula’s Citrus CocoKefir, and Tula’s Apple Cinnamon CocoKefir, are labeled to contain stevia. Whole-leaf and crude stevia extracts are not approved for food use as a sweetener. Certain highly purified steviol glycosides obtained from stevia leaves have been the subject of generally recognized as safe (GRAS) notices. FDA has not objected to the use as sweeteners of these highly refined substances, which are generally referred to as Rebaudioside A (see FDA’s GRAS notice inventory: www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing).
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Your response should be directed to Marie A. Fadden, Acting Compliance Officer, at the address listed above. You can contact Ms. Fadden at (612) 758-7172 with any questions regarding this letter.
 
                                                         
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District