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  5. Top Health Manufacturing, LLC - 671665 - 06/03/2024
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WARNING LETTER

Top Health Manufacturing, LLC MARCS-CMS 671665 —

Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Mathieu Q C Ung, Co-Owner
Recipient Title
Ms. Cynthia L. Rudd, Co-Owner
Top Health Manufacturing, LLC

1350 Calpac Avenue
Spanish Fork, UT 84660-9298
United States

Issuing Office:
Division of Human and Animal Food Operations West IV

United States

June 3, 2024 

WARNING LETTER

CMS 671665

Dear Mr. Ung and Ms. Rudd:

The U.S. Food and Drug Administration, (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 1350 Calpac Avenue, Spanish Fork, UT 84660-9298 on October 12-13, 16, 18, and 20, 2023. Based on inspectional findings and review of the product labels collected during the inspection we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.  

At the conclusion of the inspection on October 20, 2023, you were provided with a Form FDA 483, Inspectional Observations (FDA 483).  We acknowledge receipt of your correspondence received on November 10, 2023, and we address your response below, in relation to each of the noted violations.

Adulterated Dietary Supplements

The inspection of your facility on October 12-13, 16, 18, and 20, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplements Grandma’s Herbs Kidney and (b)(4) manufactured at your facility 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)], because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Your significant violations of the CGMP requirement area as follows:

1. You did not follow written procedures for quality control operations as required by 21 CFR 111.103. Specifically, you do not follow SOP0301-1, Quality Control Responsibilities, (effective date 04/05/2019):

  • The Master Manufacturing Records (MMRs) for (b)(4) do not reflect that they approved by your Quality Unit as required by your SOP 0301-0, section 4.1.5.
  • The Batch Production Records (BPRs) records for (b)(4) were not approved by the Quality Unit as required by your SOP0301-0, section 4.1.6. In addition, the batch records for (b)(4) were not reviewed and released by your Quality Unit.
  • You did not conduct periodic Good Manufacturing (GMP) internal audits of the entire plant with documented corrective actions, as required by your SOP 0301-0, section 4.1.13. An internal audit has not been conducted since 2022.
  • The calibration logs for scales located in the (b)(4) and (b)(4) rooms were not reviewed by your Quality Unit as required by your SOP 03010, section 4.1.14.
  • The Quality Unit did not review all laboratory control process and testing results, as required by your SOP 0301-0, section 4.1.16. The finished product testing results for (b)(4), and Grandma’s Herbs Kidney, lot 220107 both analyzed by (b)(4), were not reviewed by your Quality Unit prior to shipment into interstate  commerce.

We have reviewed your response dated November 10, 2023. In your response you state you will retrain your personnel and provide training records to FDA within 30 days. You did not provide any documentation; therefore, we cannot evaluate the implementation.

2. You failed to establish required specifications:

  • You did not establish an identity specification for each component as required by 21 CFR 111.70(b)(1). Specifically, your documents intended to contain component specifications do not contain a specification target or range for “Identification” or indicate a Reference or Method to be used. (b)(4) (marshmallow) root powder, Juniper berry powder, and Yarrow herb/flower powder are components in Grandma’s Herbs Kidney. (b)(4) are components in (b)(4). None of these components have a listed specification target, range, reference, or test method. In addition, when asked for component specifications for juniper berry and buchu powder used in Grandma’s Herb Kidney, you stated you did not have any.
  • You did not establish component specifications for purity and strength as required by 21 CFR 111.70(b)(2). Specifically, your documents intended to contain component specifications do not include target or range for purity or strength. (b)(4) (marshmallow) root powder, Juniper berry powder, and Yarrow herb/flower powder are components in Grandma’s Herbs Kidney. (b)(4) are components in (b)(4). None of these components have specifications for purity or strength.

We have reviewed your response dated November 10, 2023. In your response you state you will create specifications for raw materials and that you estimate it will take approximately 90 days. You did not provide any documentation of your specifications, so we cannot evaluate the implementation.

3. You did not establish specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, as required by 21 CFR 111.70 (e). Specifically, when asked by the FDA investigator, you stated you do not have any finished product specifications for you Grandma’s Herbs Kidney, and (b)(4) dietary supplement that you manufacture.

We have reviewed your response dated November 10, 2023. In your response you state you will establish specifications for component purity and strengthen within 90 days. You did not provide any documentation, so we cannot evaluate the implementation.

4. You failed to establish MMRs for your products that include all elements required by 21 CFR 111.210. Specifically, the MMR for your products Grandma’s Herbs Kidney and (b)(4) failed to include the information required by 21 CFR 111.210, such as:

  • A statement of 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).
  • Your MMR did not 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). Specifically, the MMRs for Grandma’s Herbs Kidney, and (b)(4) did not include an actual or representative label attached to the MMR or provide a physical location of the actual or representative label.
  • Written instructions including 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 master manufacturing record, as required by 21 CFR 111.210(h)(3). Specifically, your MMR for (b)(4) does not include instructions for capsule drying or packaging operations. In addition, the MMR does not contain detailed instructions for the encapsulation process.

We have reviewed your response dated November 10, 2023. In your response you state you will revise your MMRs and update FDA on your progress in 30 business days. You did not provide any documentation, so we cannot evaluate the implementation.

5. Your batch production record did not include complete information relating to the production and control of each batch as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your batch records for Grandma’s Herbs Kidney and (b)(4) failed to include:

  • Date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross reference to records where this information is retained (Grandma’s Herb Kidney preweigh, lots C230915 and C220101, Grandma’s Herbs Kidney encapsulation, lots E230902 and E220101, (b)(4), lot (b)(4), (b)(4), lot (b)(4), and (b)(4) lot (b)(4) as required by 21 CFR 11.260(c).
  • Statement of the percentage of theoretical yield at appropriate phases of processing (Grandma’s Herbs Kidney Encapsulation, lots E220101 and E230902, (b)(4), lot (b)(4), and (b)(4), lot (b)(4)) as required by 21 CFR 111.260(f).
  • The date on which each step of the master manufacturing record was performed, (Grandma’s Herbs Kidney pre-weigh, lots C220202 and C230914 and (b)(4), lot (b)(4) as required by 111.260(j)(1). 
  • Documentation of packaging operations for (b)(4), lot (b)(4), as required by 21 CFR 111.260(k).

We have reviewed your response dated November 10, 2023. In your response you state you will update your batch production and update FDA on your progress in 30 business days. You did not provide any documentation, so we cannot evaluate the implementation.

Misbranded Dietary Supplements

In addition, we reviewed your products labels collected during the inspection and have determined the Grandma’s Herbs Kidney and (b)(4) products you manufacture are misbranded under section 403 of the Act [21 U.S.C.  343] because they do not comply with the labeling requirements for dietary supplements.

Specifically, we identified the following:

1. The Grandma’s Herbs Kidney product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C.  § 343(s)(2)(C)] because the 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). Specifically, you list the ingredients parsley, cleavers, and meadowsweet as “herb” and do not identify the plant part used in the product. If the whole or entire plant is used, that information must be listed.

2. The (b)(4) product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading. The product label identifies the ingredient “candelilla wax”, but the batch record reviewed during the inspection for (b)(4), shows that candelilla wax was not added to the product despite the declaration on the label.  

3. The Grandma’s Herbs Kidney and (b)(4) products are misbranded under 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36 and 21 CFR 101.9. For example:

 - Grandma’s Herbs Kidney

  i. The product label does not list the quantitative weight of the proprietary blend using the appropriate units, which is not in accordance with 21 CFR 101.36(b)(3)(ii)(A).

  ii. The dietary ingredients of the proprietary blend do not appear to be indented, which is not in accordance with 21 CFR 101.36(c)(2).                

  iii. The nutrition information is not presented using a uniform type size, which is not in accordance with 21 CFR 101.36(e). In addition, the heading “%Daily Value” fails to be bolded.

 - (b)(4)

  i. The product label does not have a heavy bar under the final (b)(2)-dietary ingredient, which is not in accordance with 21 CFR 101.36(e)(6)(ii).

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also have the following comment:

The Grandma’s Herbs Kidney product label declares “Allergy warning: Manufactured in facility that also handles milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybean.” Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls. See Guidance for Industry: Questions and Answers Regarding Food Allergens Labeling, (Edition 5) (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-industry-questions-and-answers-regarding-food-allergenlabeling-edition-5). The firm should make every effort to ensure that they and their suppliers have adequate GMPs in place to prevent the unintentional inclusion of allergens in their products and ingredients.

Please notify this office in writing within 15 working days of the receipt of this letter of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent recurrence of the violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures. Photographic, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections.

Your written response should be sent to Director of Compliance Branch Jennifer Hicks at U.S. Food and Drug Administration, DFC Bldg 20 – W. 6th Ave & Kipling St., P.O. Box 25087, Denver, CO 80225. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Jennifer Hicks by telephone at (303) 503-9289 or by email at jennifer.hicks@fda.hhs.gov.  

Sincerely,
/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Foods-
West Division 4 

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