From April 11 through April 13, 2017, the U.S. Food and Drug Administration (FDA) inspected your facility, located at 8751 North 117 ^th East Avenue, Suite J, Owasso, Oklahoma. During the inspection, our investigators found violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations Part 111 (21 CFR Part 111). These violations cause your GnuPharma 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 found under 21 CFR Part 111.

 

We have also reviewed your GnuPharma Corporation websites, www.gnupharma.com and www.gnuwellness.com in June 2017 and again in November 2017, and the product labels for the products you manufacture and distribute. Based on our review, we have concluded that your Relief capsules, Foundation capsules, Aller-geez capsules, Fit capsules, Aller-Geez Tea, Foundation herbal tea, Relief Tea, Relief Herbal Aromatherapy, and your HNR (all flavors) Herbal Aromatherapy are in violation of section 505(a) of the Act [21 U.S.C. §§ 355(a)]. 

 

We have also reviewed the product labels for your Relief, Foundation, Fit, and Sleep capsules, and based on our review, we have concluded that these products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].

 

We acknowledge receipt of your two written responses to the FDA 483, Inspectional Observations, dated April 25, 2017, and June 6, 2017, which outline your proposed corrective actions, including removing content from your websites and submitting copies of your new quality control procedures. However, a review of your websites and your corrective actions revealed adequate corrections have not been made, as outlined below.

 

You can find the Act and FDA regulations through links in FDA's website at www.fda.gov.

                      

Unapproved New Drugs

 

The Food and Drug Administration (FDA) reviewed your product labels and your website at the internet addresses www.gnuwellness.com and www.gnupharma.com in June 2017 and again in November 2017, and determined that you take orders there for your products Relief capsules, Foundation capsules, Aller-geez capsules, Fit capsules, Aller-Geez Tea, Foundation herbal tea, Relief Tea, Relief Herbal Aromatherapy, and HNR (all flavors) Herbal Aromatherapy.  The claims on your product labeling establish that the products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or they are intended to affect the structure or any function of the body of man. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

 

Examples of some of the claims on your product labeling that provide evidence that your products are intended for use as drugs include:

 

Relief capsules:

Foundation capsules:

Aller-geez capsules:

Fit capsules:

Aller-Geez Tea:

Foundation herbal tea:

Relief Tea:

HNR Herbal Aromatherapy (all flavors):

Relief Herbal Aromatherapy:

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) of the Act [21 U.S.C. 321(p)]. 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 and information demonstrating that the drug is safe and effective for its labeled uses.

 

Adulterated Dietary Supplements

 

Even if your Fit, Foundation, and Relief products did not have therapeutic claims which make them unapproved new drugs, these products and other dietary supplement products that you manufacture would be adulterated within the meaning of 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 Part 111).

 

The following CGMP violations were observed during the inspection of your facility:

 

1.    You failed to establish a specification for any point, step, or stage 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 master manufacturing record, as required by 21 CFR 111.70(a). Specifications include those that must be established for components that you use in the manufacture of a dietary supplement (21 CFR 111.70(b)), for in-process production (21 CFR 111.70(c)), for dietary supplement labels and packaging (21 CFR 111.70(d)), and to ensure the quality of the dietary supplement (21 CFR 111.70(e)).  Specifically:

 

a.  You failed to establish the following required component specifications under 21 CFR 111.70 (b) for each component that you use in the manufacture of a dietary supplement:

b.  You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements, and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1).

 

c.  You failed to establish specifications for each dietary supplement that you manufacture 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).

 

We have reviewed your responses dated April 25, 2017, and June 6, 2017.  In your April 25, 2017, response you provided a copy of the procedure for Receiving and Processing Raw Materials.  This response is inadequate because it is a written procedure which describes how you receive raw materials, sample, and stage until dispositioned.  It does not address the specifications that you have established for each component used in the manufacture of your dietary supplements.  Furthermore, your updated June 6, 2017, response states that you have developed a set of specifications that your herbs must adhere to; however, we are unable to evaluate the adequacy of your response because you did not provide copies of component specifications, nor did you provide evidence of having established in-process and finished product specifications.  We will evaluate the adequacy of your corrective action at our next inspection.

 

2.    You failed to establish and follow written procedures for quality control operations, as required by 21 CFR 111.103.   Specifically, you told our investigator that you did not establish and follow written procedures for quality control operations.  You also must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65.

 

We have reviewed your responses dated April 25, 2017, and June 6, 2017, and determined that they are inadequate.  In your April 25, 2017, response you provided a copy of "Procedure for Quality Control Operations," and in your June 6, 2017, response you state that all efforts in documenting your quality control procedures are complete.  As submitted, your "Procedure for Quality Control Operations" does not meet the requirements of 21 CFR 111.105 for quality control operations.  For example, your "Procedure for Quality Control Operations" does not include information about quality control personnel approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength or composition of a dietary supplement [21 CFR 111.105(a)].

 

3.    You failed to prepare and follow a written master manufacturing record for each unique formulation of your dietary supplement products 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 investigator that you did not have written master manufacturing records for your dietary supplement products.

 

We have reviewed your responses, dated April 25, 2017, and June 6, 2017. We are unable to evaluate the sufficiency of your responses because you failed to provide documentation that you have prepared a master manufacturing record for each unique formulation and batch size of your dietary supplement products.  Furthermore, even if we could evaluate the sufficiency of your responses with that documentation, we find your April 25, 2017, response inadequate because you provided a master manufacturing record template that does not include all the required elements specified in 21 CFR 111.210. For example, it does not include a complete list of the components to be used as required under 21 CFR 111.210(b).

 

4.    You failed to prepare a batch production record every time you manufacture a batch of your dietary supplement products, as required by 21 CFR 111.255(a). Specifically, during the inspection, our investigators observed that you did not have batch production records for any batches of dietary supplements produced between March 2016 and April 2017.

 

We have reviewed your responses, dated April 25, 2017, and June 6, 2017.  In your updated June 6, 2017, response you state that data has been gathered to support batch records for March, July, and September 2016 batch builds; however, we are unable to evaluate the sufficiency of your response because you did not provide any documentation to support production of your dietary supplement products. We will evaluate the adequacy of your corrective actions at our next inspection.

 

5.    You failed to establish and follow written procedures for fulfilling the requirement for equipment and utensils under 21 CFR 111.25, including written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment, as required by 21 CFR 111.25(b); as well as 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, during the inspection, our investigators observed that you did not have written procedures for fulfilling the requirement for equipment and utensils under 21 CFR 111.25.

 

Further, you failed to make and keep records documenting any calibration, each time the calibration is performed, for instruments that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(3). Specifically, during the inspection our investigator observed that you did not have calibration records for the (b)(4) scale used to weigh dietary ingredients used in the manufacture of your dietary supplements.

 

You also failed to make and keep documentation of the date of use, maintenance, cleaning and sanitizing of equipment, as required by 21 CFR 111.35(b)(2). Specifically, during the inspection, our investigator observed that you did not have records indicating that you clean and sanitize equipment and utensils used in manufacturing, before the dietary supplements were produced.

 

We have reviewed your responses, dated April 25, 2017, and June 6, 2017.  You provided copies of "Procedure for Calibration Maintenance" and "Procedure for Procedure for Cleaning (Labs)" in your April 25, 2017, response.  We find your "Procedure for Calibration Maintenance" inadequate because it does not address how you perform (b)(4) calibrations, checks, and inspections of your automated, mechanical, and electronic equipment prior to use in the manufacture of your dietary supplements.  Additionally, you state in your updated April 6, 2017, response that the uncalibrated scale observed during the inspection has now been calibrated by a certified professional according to its product manual; however, we are unable to evaluate the sufficiency of this corrective action because you did not provide documentation to support that the scale is calibrated.  We will assess the adequacy of that corrective action at our next inspection.

 

Furthermore, we find your "Procedure for Cleaning (Labs)" inadequate because it does not address how you maintain, clean, and sanitize all equipment and utensils used in the manufacture of your dietary supplements.  Your procedure is specific to the cleaning of general contact surfaces in your labs and does not include procedures for cleaning and sanitizing equipment and utensils.

 

Misbranded Dietary Supplements

 

Even if your GnuPharma Corporation websites and labels did not contain claims that cause some of your products to be unapproved new and misbranded drugs, they would still be misbranded foods under section 403 of the Act [21 U.S.C. § 343] in that the labels for these products do not comply with the labeling requirements in 21 CFR 101, as follows:

 

1.   Your Relief, Foundation, Fit, and Sleep products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the 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. For example: 

2.    Your Fit product is misbranded within the meaning of section 403(s)(2)(A) of the Act [21 U.S.C. §343(s)(2)(A)] in that the label fails to list the name of each dietary ingredient of the supplement that is described in section 201(ff) of the Act and the quantity of each such dietary ingredient.  According to the formulation you provided during the inspection, your Fit product contains the ingredients (b)(4) and (b)(4).  The product label you provided during the inspection does not list these botanical ingredients.  Further, the label lists ingredients that are not in the product, according to the formulation, including "sage extract," "peppermint," "red clover," and "licorice."

 

3.    Your Relief, Foundation, Fit, and Sleep products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail 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:

4.    Your Relief, Foundation, Fit, and Sleep 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 presentation of nutrition information does not comply with 21 CFR 101.36. For example:

5.    Your Relief, Foundation, Fit, and Sleep products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example, the Relief product dosage is to take 2-3 capsules for maintenance, or for increase support to take 3-6 capsules, or for a therapeutic dose to take 7-9 capsules. The serving size listed should be 9 capsules.

 

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist 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 implementing regulations. You should take prompt measures to correct all violations described in this letter. Failure to promptly correct these violations may result in enforcement action by the FDA without further notice, including injunction or seizure. 

 

We offer the following additional comments:

 

1.    Your firm received a letter dated March 30, 2017, from the Center for Food Safety and Applied Nutrition (CFSAN) regarding an adverse event entered into the CFSAN Adverse Event Reporting System (CAERS). This letter explained an adverse event that was reported was allegedly associated with one of your products, Relief, and that FDA has not evaluated this report or associated it with the use of your product, Relief.  However, based on information collected during the inspection of your firm, it does not appear that you conducted an investigation of this complaint. Please note that the requirements of 21 CFR 111.560 include that all complaints must be reviewed by a qualified person to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR Part 111, and also that quality control personnel must review and approve the decisions about whether to investigate a product complaint.    

 

For your information, section 761(c) of the Act requires that you submit a report of a serious adverse event associated with any of your dietary supplements no later than 15 business days after a report of the event is received through the address or phone number provided on your product labels. These serious adverse event reports must be submitted under the MedWatch Form 3500A. More information on adverse event reporting can be found on FDA's website at www.fda.gov, in the publication "Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection."

 

2.    It appears that your complaint forms (GnuPharma Laboratory Testing Form for Customer Complaint Inquiry and GnuPharma Process Data Collection Form) do not meet the requirements of 21 CFR 111.570(2)(ii)(C) and 21 CFR 111.570(2)(ii)(D) in that there is no provision to record the date and nature of the complaint; this information is also not included as required complaint information in the SOP for Handling Customer Complaint & Customer Satisfaction.

 

3.    Your firm's name and address are not listed on the correct panels of the Relief, Foundation, Fit, and Sleep labels, 21 CFR 101.2(b), and there is intervening material between the nutrition information and the name and address, 21 CFR 101.2(e).

 

4.    The FDA disclaimer statement on the Relief, Foundation, Fit, and Sleep product labels is not presented correctly using the language that is given in 21 CFR 101.93.

 

5.    Your Relief, Foundation, and Sleep labels list the ingredient Theobromine cocoa, which is not the correct Latin binomial name.  It should be Theobroma cacao.

 

6.    The dietary ingredients contained in the proprietary blend are not indented under the term "Proprietary Blend" as required by 21 CFR 101.36(c)(2) on the labels of your Relief, Foundation, Fit, and Sleep products.

 

7.    We note that the Foundation, Relief, Sleep, and Fit product labels all declare the same 697 mg quantitative amount per serving of their proprietary blends. We suggest that your firm check this amount on the labels for possible typographical or other errors.

 

You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, you should include documentation of your corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies. 

 

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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

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