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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Healthwest Minerals, Inc. dba Mt. Capra Products 2/28/13

  

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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
 
Telephone:      425-302-0340
FAX:    425-302-0402

 

February 28, 2013
 
VIA OVERNIGHT MAIL
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 13-14
 
Joseph Stout, President
Healthwest Minerals, Inc., dba Mt. Capra Products, Mt. Capra Whole Foods, and Mt. Capra Cheese
279 SW 9th Street
Chehalis, Washington 98532
 
 
WARNING LETTER
 
Dear Mr. Stout:
 
Between May 15 and June 26, 2012, the U.S. Food and Drug Administration (FDA) inspected your facility, located at 279 SW 9th Street, Chehalis, Washington. The inspection revealed violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements (21 CFR Part 111). These violations cause your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, Strawberry Splash! Deep2 30, Double Bonded Protein, and CapraGreens 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 the CGMP regulations for dietary supplements.
 
However, this letter should not be interpreted to mean that FDA agrees with the characterization of your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, Strawberry Splash! Deep2 30 products as dietary supplements.  In fact, the labels for your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, Strawberry Splash! Deep2 30 products that we collected during our inspection revealed that these products may be represented for use as conventional foods. Indeed, these labels bear “Nutrition Facts” panels. In addition, labeling in an online catalog for your products available on your website refers to your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, Strawberry Splash! Deep2 30 products as “Our Most Delicious Drink Yet!” See http://www.mtcapra.com/images/mtcapra_catalog_2011.pdf, the “drink” nomenclature implying a conventional food use. Although it appears that you may have changed some of these representations on your website (for instance, images of labels available at http://www.mtcapra.com/DEEP-2-30 now bear “Supplement Facts” panels instead of “Nutrition Facts” panels), these corrections will have to be verified during our next inspection. Section 201(ff)(2) of the Act provides that dietary supplements do not include products represented for use as conventional foods [21 U.S.C. § 321(ff)(2)]. If your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, Strawberry Splash! Deep2 30 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 may find the Act and related regulations through links on FDA's home page at www.fda.gov.
 
The inspection revealed the following violations of FDA’s dietary supplement CGMP regulations:
 
  1. You failed to establish product specifications for the identity, purity, strength and composition of the finished batch for each dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).
 
Specifically, you have not established product specifications for your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, Strawberry Splash! Deep2 30, or Double Bonded Protein products.
 
  1. You failed to include required information in your master manufacturing records (MMR), as required by 21 CFR 111.210.  Specifically, the MMR for your CapraGreens product failed to include the following required information:
 
a.  Your MMR fails to include a statement of any intentional overage amount of a dietary ingredient, as required by 21 CFR 111.210(e);
 
b.  Your MMR fails to include a statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made, as required by 21 CFR 111.210(f);
 
c.  Your MMR fails to include a description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g);
 
d.  Your MMR fails to include written instructions as required by 21 CFR 111.210(h).  Specifically, your MMR failed to include written instructions for (1) specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the control of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h)(1)]; (2) procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)]; and (3) specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h)(3)].
 
  1. You failed to include required information in your batch production records (BPR), as required by 21 CFR 111.260. Specifically, the BPR for your CapraGreens product failed to include the following required information:
 
a.  Your BPR fails to include the batch, lot, or control number of the finished lot of dietary supplement, as required by 21 CFR 111.260(a)(1);
 
b.  Your BPR fails to include the identity of the equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b);
 
c.  Your BPR fails to include the date, time, and maintenance, cleaning, and sanitizing of equipment and processing lines in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained, as required by 21 CFR 111.260(c);
 
d.  Your BPR fails to include a statement of the actual yield and a statement of the percentage of the theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f);
 
e. Your BPR does not include documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g), as required by 21 CFR 111.260(i).
 
  1. You failed to collect representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications, as required by 21 CFR 111.80(c).
 
Specifically, our investigator found that your firm does not collect representative samples of finished batches of your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, Strawberry Splash! Deep2 30, or Double Bonded Protein products. 
 
  1. You failed to hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a).
 
Specifically, you verbally confirmed to our investigator that you do not hold reserve samples.
 
  1. You failed to have all required records readily available during the retention period for inspection and copying by FDA when requested, as required under 21 CFR 111.610(a). Specifically, you failed to have the following records available:
    1. Records of the written procedures for manufacturing operations, as required by 21 CFR 111.375(b));
    2. Records of the written procedures for holding and distributing operations, as required by 21 CFR 111.475(b)(1);
    3. Records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b);
    4. Records of the written procedures for the quality control operations, as required by 21 CFR 111.140(b)(1);
    5. Records of the written procedures for cleaning the physical plant and pest control, as required by 21 CFR 111.23(b);
  1. You failed to establish and follow written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(c). 
 
Specifically, our investigator determined that you have no written procedures for maintaining, cleaning and sanitizing hoses, cook room kettles, drying equipment, hammer mills, holding tanks, protein drying box, or packaging equipment.
 
  1. You failed to establish written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required under 21 CFR 111.25(a).
 
Specifically, our investigator determined that you lack written procedures for calibrating scales, pH meters, and other equipment used in the manufacturing of your dietary supplements. 
 
  1. You failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required under 21 CFR 111.14(b)(2). Although you told our investigator that you provide periodic training for all employees, you did not make or keep any documentation related to training.
 
This letter is not intended to be an all-inclusive list of violations within your facility.  It is your responsibility to ensure that your firm and the products you market are in compliance with the Act and FDA’s implementing regulations. 
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice, such as seizure and/or injunction.
 
In addition to the above violations, we also have the following comments:
 
a. Lack of % Daily Value on the Nutrition Facts for “Best Toddler Goat Milk Formula” which you package for Perfectly Healthy (as required by 21 CFR 101.9(c)(7)(i));
 
b. Lack of listing flavoring ingredients in your Coconut Dream Deep2 30, Banana Smoothie Deep2 30, and Strawberry Splash! Deep2 30 products (as required by 21 CFR 101.22(h)).  We acknowledge that product labels shown on your website have been corrected to list “natural flavors”; use of corrected labels will be verified at the next inspection of your facility.
 
Please notify this office, in writing, within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations described above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show corrections. If you cannot complete all corrections within fifteen (15) days, please state the reason for the delay and the time 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 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.
 
Please send your reply to the Food and Drug Administration, Attn: Heidi Marks, Compliance Officer, at the above letterhead address. If you have any questions regarding issues in this letter, please contact Heidi Marks at 425-302-0418 or at the above address.
 
Sincerely,
/S/
Charles M. Breen
District Director
 
 
cc:     Claudia Coles
         Compliance Director
         Washington State Department of Agriculture