Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625846.htm
Timestamp: 2019-01-16 03:28:17
Document Index: 344313721

Matched Legal Cases: ['§ 321', '§ 352', '§ 331', '§ 342', 'art 111', '§ 342', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 321']

DynaPro International, Inc. 10/31/18
Office of Human and Animal Foods - Division IV West
Mr. Jason Asplund
DynaPro International, Inc.
Kaysville, UT 84037-1114
Ref. No: HAF4W(DEN)-19-01-WL
Dear Mr. Asplund:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, DynaPro International, Inc., located at 451 North Main St., Kaysville, Utah, from May 2 - 18, 2018. Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at http://www.dynaprointernational.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
FDA reviewed your website at http://www.dynaprointernational.com in September 2018 and has determined that you take orders there for the product DynaPro Spirulina. FDA also reviewed product labels collected during the May 2018 inspection. The claims on your labels and website establish that your DynaPro Spirulina, DynaPro Can-D-Da Relief, and DynaPro Para-Gone products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of some of the claims observed on your website and product labels that provide evidence that these products are intended for use as drugs include the following:
Product: DynaPro Spirulina (website)
“[Spirulina] has helped in the healing of ulcers and the treatment of diabetes.”
Product: DynaPro Can-D-Da Relief (product label)
“Candida is a single cell fungus which belongs to the vegetable kingdom. It can be activated when resistance is lowered by sickness, injury, or surgery. This fungus normally lives on the mucous membranes of the intestines & digestive tract. Symptoms of candida include: extreme tiredness, rashes, yeast infections, intestinal problems, pain and bloating.”
Product: DynaPro Para-Gone (product label)
“Parasites are usually carried on plants grown in or on the ground, such as carrots, potatoes, lettuce, radishes, etc. They can cause extreme fatigue and be a factor in low blood sugar.”
Your products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. 321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)]), can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your DynaPro Spirulina product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment. Therefore, it is impossible to write adequate directions for a layperson to use this product safely for its intended purposes. Accordingly, DynaPro Spirulina fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Your dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). Additionally, even if your DynaPro Spirulina, DynaPro Can-D-Da Relief, and DynaPro Para-Gone products did not have therapeutic claims that make them unapproved new drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
The following CGMP violations were observed during the May 2018 inspection:
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, as required by 21 CFR 111.103. Specifically, you rely exclusively on your “GMP & Quality Control Policy Manual” as your sole written procedure for the responsibilities of the quality control operations; however, this document fails to establish written procedures for the responsibilities of the quality control operations that are specific to the operations you perform. Quality control operations for packaging and labeling operations must include approving for release, or rejecting, any packaged and labeled dietary supplement for distribution (21 CFR 111.127(h)).
As a dietary supplement distributor that contracts with a manufacturer to manufacture a dietary supplement that you distribute under your own label, you have an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [see 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of those products are in compliance with dietary supplement CGMP requirements.
You receive finished bulk powder and unlabeled bottled dietary supplements from a contract manufacturer that manufactures the dietary supplements on your behalf, which you package and/or label, hold, and distribute into interstate commerce. As such, quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged as specified in the master manufacturing record (21 CFR 111.105), and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)).
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you state that you have established responsibilities for the quality control operations as outlined in your updated Standard Operating Procedure (SOP), but you did not include updated SOPs with your response. We will evaluate the sufficiency of your written procedures for the responsibilities of the quality control operations during our next inspection.
You failed to prepare a batch production record every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255(a). Under 21 CFR 111.255 and 111.260, you must prepare a batch production record that includes complete information relating to the production and control of each batch for those aspects of the production process you perform, including documentation of packaging and labeling operations (see 21 CFR 111.260(k)) and quality control operations (21 CFR 111.260(l)). Specifically, you have not established written batch records for any of the dietary supplements you package and/or label.
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you provided a copy of a batch record from the contract manufacturer and indicated that you are in the process of preparing batch records for your packaging and labeling operations. We will evaluate the sufficiency of your batch records during the next inspection.
You failed to prepare and follow a written master manufacturing record (MMR) for each batch size of a dietary supplement that you manufacture, as required by 21 CFR 111.205(a). Under 21 CFR 111.205 and 111.210, you must prepare an MMR that includes a description of packaging and a representative label, or a cross-reference to the physical location of the actual label (21 CFR 111.210(g)). Specifically, you have not established master manufacturing records for any of the dietary supplements you package and/or label.
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you state that you intend to implement MMRs for your packaging and labeling operations. We will evaluate the sufficiency of your MMRs during the next inspection.
You failed to establish and follow written procedures for fulfilling requirements for returned dietary supplements as required by 21 CFR 111.503. Specifically, you have not established written procedures for returned dietary supplements. Once you have established written procedures for returned dietary supplements, you must make and keep records of these written procedures, as required by 21 CFR 111.535.
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you state that you will establish written procedures for the return of dietary supplements. We will evaluate the sufficiency of your procedures for returned dietary supplements during the next inspection.
You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560. Specifically, you have not established written procedures for product complaints, and you do not make and keep records of product complaints. Once you have established written procedures for product complaints, you must make and keep records of these written procedures, as required by 21 CFR 111.570(b)(1).
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you state that you intend to implement written procedures for documenting product complaints. We will evaluate the sufficiency of your written procedures for product complaints during the next inspection.
You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distribution operations. Once you have established written procedures for holding and distribution operations, you must make and keep records of these written procedures, as required by 21 CFR 111.475(b)(1).
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you state that you intend to update your SOP to include procedures for holding and distribution operations. We will evaluate the sufficiency of your written procedures for holding and distributing operations during the next inspection.
You failed to establish and follow written procedures for packaging and labeling operations as required by 21 CFR 111.403. Specifically, you did not establish written procedures for your packaging and labeling operations. Once you have established written procedures for your packaging and labeling operations, you must meet the requirements that apply to packaging and labels as required by 21 CFR 111.410. For example, you must control the issuance of labels and the reconciliation of labels used (21 CFR 111.410(b)), and you must be able to determine the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution (21 CFR 111.410(d)). Although you apply labels to your dietary supplement products, you do not include a lot number or other unique identifier. A lot number or other unique identifier is necessary to determine the complete manufacturing history and control of your dietary supplements.
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you state that you intend to include batch numbers on all labels and document the corresponding batch number on your copy of each customer’s invoice. You state that this information will be included in the update of your SOP along with a procedure to document the issuance of each label. We will evaluate the sufficiency of your written procedures for packaging and labeling operations during the next inspection.
You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distributed, as required by 21 CFR 111.83(a). Specifically, you did not collect and hold reserve samples of the dietary supplements you distribute.
We have reviewed your response, dated June 1, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. In your response, you state that you keep samples of each product that you package and label and will begin to hold these samples in a separate area that corresponds to each product and label. We note that you must maintain a reserve sample for each lot. We will evaluate the sufficiency of your corrective actions, including your compliance with the requirements under 21 CFR 111.83, at the next inspection.
Further, even if the labeling for your DynaPro Can-D-Da Relief and DynaPro Para-Gone products did not make therapeutic claims which make the products unapproved new drugs, these products and your DynaPro Stress Remedy, DynaPro G Plus, DynaPro GEM, DynaPro Vanilla Supreme, DynaPro Berry Supreme, (b)(4), and (b)(4) products would be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and the implementing regulations (21 CFR 101). Specifically, during the inspection of your facility, our investigator collected labels associated with many of the products you package, label, and/or hold. Our review of your product labels revealed that your products are misbranded within the meaning of section 403 of the Act as follows:
1. Your DynaPro Can-D-Da Relief, DynaPro Para-Gone, DynaPro Stress Remedy, DynaPro G Plus, DynaPro GEM, DynaPro Vanilla Supreme, DynaPro Berry Supreme, (b)(4), and (b)(4) products 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 nutrition information for your products do not comply with 21 CFR 101.36. For example:
Your DynaPro Can-D-Da Relief, DynaPro Para-Gone, DynaPro Stress Remedy, DynaPro G Plus, and DynaPro GEM products fail to declare any nutrition information, as required by 21 CFR 101.36.
Your DynaPro Vanilla Supreme, DynaPro Berry Supreme, and (b)(4) products fail to present nutrition information on the nutrition label using the title “Supplement Facts” and in accordance with 21 CFR 101.36. Furthermore, these products fail to declare nutrition information in an appropriate format outlined in 21 CFR 101.36(e).
Your DynaPro Vanilla Supreme product fails to declare the amount by weight per serving of each dietary ingredient required to be listed under 21 CFR 101.36(b)(2)(i), as required by 21 CFR 101.36(b)(2)(i)(A). The product contains calcium but fails to declare the quantitative amount of this dietary ingredient.
Your (b)(4) product label declares calories per serving which do not correlate with the declared macronutrients. Furthermore, the %DV for Total Fat does not correlate with the declared quantitative amount of total fat per serving in accordance with 21 CFR 101.36(b)(2).
Your (b)(4), DynaPro Vanilla Supreme, and (b)(4) product labels list zero amounts of (b)(2)-dietary ingredients such as sodium, protein, iron, or fiber. Any (b)(2)-dietary ingredients must not be declared if they are not present or are present in amounts that can be declared as zero in 21 CFR 101.9(c), in accordance with 21 CFR 101.36(b)(2).
Your (b)(4) product label fails to declare the quantitative amount of the (b)(2)-dietary ingredient, dietary fiber, with the % Daily Value within the listing of the (b)(2)-dietary ingredients, in accordance with 21 CFR 101.36(b)(2).
2. Your DynaPro Can-D-Da Relief, DynaPro Para-Gone, DynaPro Stress Remedy, DynaPro G Plus, DynaPro GEM and (b)(4) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. In particular, for the capsule products, we note that the ingredients that make up the capsule itself are not declared. Furthermore, for the (b)(4) product the specific trace minerals of the “(b)(4) minerals” are not declared. In addition, the DynaPro Stress Remedy product label declares Vitamin B Complex which is not the common or usual name of an ingredient. We also note that for the Can-D-Da Relief product, the “organic tincture” does not indicate the ingredient(s) that make up the tincture.
3. Your (b)(4) and (b)(4) products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because they do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
4. Your DynaPro Berry Supreme product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label lists “whey” but fails to declare the major food allergen, milk, as required by section 403(w)(1) of the Act.
5. Your DynaPro Para-Gone, DynaPro Stress Remedy, DynaPro G Plus, and DynaPro GEM products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because each 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). For example, if a whole or entire plant is a dietary ingredient or source of a dietary ingredient, that information must be listed next to the standardized common name and/or Latin binomial name.
6. Your DynaPro Vanilla Supreme product label is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] in that the product contains coloring and the label fails to state that fact in accordance with 21 CFR 101.22(k)(2). Color additives not subject to certification and not otherwise required to be declared by their respective common or usual names may be declared as “Artificial Color,” “Artificial Color Added,” or “Color Added” (or by an equally informative term that makes clear that a color additive has been used in the dietary supplement).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law, including the Act and its implementing regulations.
You should take prompt action to correct violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
In addition, insofar as you intend to market your products as dietary supplements, we offer the following comments:
Your DynaPro Vanilla Supreme product label declares the statement of identity “dietary supplement.” However, we note the label also declares, “Use it as a snack or a full meal replacement.” Per Section 201(ff)(2)(B) of the Act [21 U.S.C. § 321(ff)(2)(B)], the term “dietary supplement” means a product that is not represented for use as a conventional food or as a sole item of a meal or the diet. As such, your product cannot be labeled as a dietary supplement and simultaneously be represented for use as a conventional food or as a sole item of a meal or the diet.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
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 to costs from the responsible party for the domestic facility.
Address your reply to the U.S. Food and Drug Administration; Attn: Caroline H. Le, Pharm.D., Compliance Officer, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Dr. Le at (303) 236-3045 if you have any questions about this matter.
District Director, FDA Denver District
Office of Human and Animal Foods – Division IV West