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WARNING LETTER

KCE LLC MARCS-CMS 492660 —


Recipient:
Recipient Name
Allan M. Yoza
KCE LLC

13-1399 Kamaili Rd.

Pahoa,, HI 96778
United States

Issuing Office:
San Francisco District Office

United States


  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-6700

 

WARNING LETTER
 
 
August 26, 2016                                                                    
           
           
Via UPS
Overnight Delivery
Return Receipt Requested
 
 
Allan M. Yoza, Owner
KCE, L.L.C.
13-1399 Kamaili Rd.
Pahoa, HI 96778
FEI: 3011320745                                                                                          
 
Dear Mr. Yoza:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 13-1399 Kamaili Rd., Pahoa, HI 96778 from December 17, 2015 through December 22, 2015.  You manufacture products you describe as dietary supplements at this facility. We found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). To the extent that you intend to market your HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products as dietary supplements, these violations cause these 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov
 
Dietary Supplements CGMPs
 
The inspection revealed the following significant violations of the CGMP requirements for the following products as dietary supplements: HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice”, HEALING noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice:
 
1.    You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement 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, your firm informed our investigator that you did not have MMRs for any of the dietary supplement products you manufacture, including HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice”, and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice”, We note that an MMR must include the information specified under 21 CFR 111.210.
 
We acknowledge in your response dated January 8, 2016, that you are working to fix all errors within your documenting systems. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
2.    You failed to prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 111.255(a). Specifically, during the inspection you stated that you did not prepare and maintain production records for HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice” dietary supplement products. We note that a BPR must include the information specified under 21 CFR 111.260.
 
We acknowledge your response, dated January 8, 2016; we intend to verify the adequacy of your corrective action at a future inspection.
 
3.    You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you stated to our investigator that you do not conduct identity testing on any of the dietary ingredients used to produce the HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice”, and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice dietary supplement products you manufacture. Additionally, note that in order to test you must first establish component specifications for identity, purity, strength, composition, and limits for contaminates; as required by 21 CFR 111.70(b).
 
We acknowledge your response, dated January 8, 2016; we intend to verify the adequacy of your corrective action at a future inspection.
 
The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling.  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 all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations.  You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction. 
 
We also offer the following comments:
 
We note that you intend to market your products HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice” as dietary supplements, but the product labels we collected during our inspection revealed that these products include representations for use as conventional foods. Specifically, the labels for your HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice” product labels contain the statement of identity on the principle display panel as “juice” and “100% pure goji juice” or “100% pure noni juice.”  This statement of identity implies that these products are used as beverages, as juice is a category of conventional food beverages.  Your product labels also include a Nutrition Facts Panel rather than a Supplement Facts panel, as required for dietary supplement products. Finally, your website labeling includes a number of representations and testimonials that imply your noni juice products are for conventional food use, including statements such as:
 
-          “100% natural farm direct juice;”
-          “Noni recommends flavoring our pure Noni Juice with natural grape, cranberry apple or blueberry juice as needed to give it a delicious fruity taste;”
-          “Completely pure, with NO additives such as water, sugar, fruit juice, preservatives;” and
-          Testimonials suggesting: “drinking a couple of ounces of juice in the morning” and “I take about 4oz. of noni daily.”
 
Section 201(ff)(2)(B) of the Act provides that dietary supplements do not include products represented for use as conventional foods [21 U.S.C. § 321(ff)(2)(B)]. If your HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice” 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).
 
Our 2014 final guidance relating to the determination between liquid dietary supplement products and conventional food beverages can be found on our website: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm381189.htm.  
 
In addition we note that insofar you intend to market your products as dietary supplements, we offer these additional comments:
  • Your response, dated January 8, 2016, to Observation 5, we note that the documentation you provided details various job descriptions. However, it is not clear whether these job descriptions for each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, has the education, training, or experience necessary to perform the person’s assigned functions [21 CFR 111.12(c)]. Further, we note that documentation of training should be kept in accordance is 21 CFR 111.14(b)(2).  
  • We also note that you are required to keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces [21 CFR 111.15]. However, we observed that you did not properly store processing equipment, cut overgrown weeds, and remove litter and waste within the immediate vicinity of the physical plant so that it does not attract pests, harbor pests, or provide pests a place for breeding, as required by 21 CFR 111.15(a)(1). During the inspection, our investigator also observed overgrown weeds, visible mud patches, and other debris adjacent to process storing equipment (e.g, green 500 gallon plastic containers with drains where noni juice is stored). 
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary 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.
 
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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Your written response should be sent to Lawton W. Lum, Director of Compliance at the address noted above and reference unique identifier 492660.  If you have any questions concerning this letter, please contact Compliance Officer Lance De Souza at (510) 337-6873.
 
Sincerely,
/S/
Kathleen M. Lewis, J.D.
District Director
San Francisco District

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