Inspections, Compliance, Enforcement, and Criminal Investigations

Total Health Advanced Nutrition, Inc. 5/29/15

  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
          FAX: (612) 334-4142 

 

May 29, 2015
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                           
Refer to MIN 15 – 11
 
 
David D. Lu
Chief Executive Officer
Total Health Advanced Nutrition, Inc.
5182 Central Avenue NE
Columbia Heights, Minnesota 55421
 
Dear Mr. Lu:
 
On October 28-29 and November 3, 2014, the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 5182 Central Avenue NE, Columbia Heights, Minnesota. This inspection found that your firm manufactures and distributes dietary supplements under your firm’s label, NutrivityRX, namely, EDTA Oral Chelation Nuvi-Detox and Nuvi-JointRx.
 
During the inspection the investigator identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (21 CFR), Part 111. These violations cause your dietary supplements 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 regulations for dietary supplements. You can find the Act and related regulations through links on FDA’s internet home page at www.fda.gov.
 
The inspection revealed the following violations:
 
1.    You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the EDTA Oral Chelation Nuvi-Detox dietary supplement you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement, as required by 21 CFR 111.70(e). 
 
Once you have established the above specifications, you must verify that the specifications are met in accordance with 21 CFR 111.75(c), and you must make and keep records in accordance with 21 CFR 111.95(b).
 
Further, you failed to establish specifications for the Nuvi-JointRx dietary supplement you receive from a supplier for labeling as a dietary supplement (and for distribution rather than for return to the supplier) to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). 
 
Once you have established such specifications, you must verify these specifications are met in accordance with 21 CFR 111.165(b) and 111.165(c). In addition, you must make and keep records in accordance with 21 CFR 111.95(b) and 111.180. 
 
We received your written response dated November 7, 2014, which indicates the actions you have taken with respect to your EDTA Oral Chelation Nuvi-Detox products and the audit of a private company’s facility from which you purchased supplements to be relabeled as Nuvi-JointRx.  However, your written response did not include supporting documentation of any specifications or verification steps and we are therefore unable to verify the adequacy of the corrective actions you describe.
 
2.    You failed to prepare a written master manufacturing record for the EDTA Oral Chelation Nuvi-Detox 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). 
 
We received your written response dated November 7, 2014, which indicates that you established master manufacturing records on November 5, 2014. However, your response is inadequate in that you did not provide any supporting documentation that you had established these master manufacturing records.
 
3.    You failed to establish batch production records for your EDTA Oral Chelation Nuvi-Detox product in accordance with the requirements in 21 CFR 111.255 and 111.260.  You must prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). At the time of the inspection the FDA investigator observed that you did not have batch production records for your EDTA Oral Chelation Nuvi-Detox product, lot 901908, which was available for sale at your establishment.
 
We received your written response dated November 7, 2014, which indicates that you began keeping batch production records on November 5, 2014. However, your response is inadequate in that you did not provide supporting documentation that you had established these batch production records.
 
4.    You failed to establish any of the following specifications for the EDTA Oral Chelation Nuvi-Detox product you manufacture, such as identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1); component specifications for each component that you use in the manufacture of a dietary supplement that are necessary to ensure that specifications of the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2); and limits on those types of contamination that may adulterate, or may lead to adulteration of, the finished batch of the dietary supplements to ensure quality of the dietary supplements, as required by 21 CFR 111.70(b)(3).
 
Once you have established the specifications for each component, you must verify that the specifications are met in accordance with 21 CFR 111.75(a), and you must make and keep records in accordance with 21 CFR 111.95(b). 
 
We received your written response dated November 7, 2014, which indicates that on November 5, 2014, you began to request specification reports from your suppliers for each ingredient that you order, or perform identity testing if the supplier’s test does not qualify. Your response is inadequate in that you must establish an identity specification for each dietary ingredient and confirm its identity through appropriate tests or examinations, as required by 21 CFR 111.75(a)(1)(i).  You provided no testing data to demonstrate that you meet this requirement for the ingredients you use to manufacture your products.  This requirement cannot be met by your ingredient supplier’s testing report.
 
5.    You failed to establish and follow written procedures for the responsibilities of the quality control operations for your EDTA Oral Chelation Nuvi-Detox and Nuvi-JointRx  products, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103, and, once established, you must implement quality control operations according to 21 CFR 111.65.  Further, you failed to designate a person responsible for your quality control operations, as required by 21 CFR 111.12(b).
 
We received your written response dated November 7, 2014, which indicates that you intended to have quality control operations in place by December 31, 2014. However, your response is inadequate in that you did not provide written procedures or records showing how you plan to implement your quality control operations. 
 
6.    You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of your EDTA Oral Chelation Nuvi-Detox product or for the labeling and holding of your Nuvi-JointRx product to ensure the quality of the dietary supplement, as required by 21 CFR 111.55. 
 
We received your written response dated November 7, 2014, which indicates that you planned to implement a system of production and process controls on or before December 31, 2014. However, your response is inadequate because you did not provide further supporting documentation to show the implementation of your production and process controls. 
 
7.    You failed to maintain documentation to permit you to determine the complete manufacturing history and control of your Nuvi-JointRx product through distribution, as required by 21 CFR 111.410(d).  For example, you do not maintain records covering the original lot number and manufacturing history (e.g., invoices, manufacturing date, certificate of analysis, etc.) for the product.
 
We received your written response dated November 7, 2014, which indicates that you have started using original lot numbers and expiration dates provided by your supplier.  However, your response is inadequate in that you did not provide documentation that demonstrates that you maintain complete manufacturing history records. 
 
8.    You failed to establish procedures for holding and distribution operations of your EDTA Oral Chelation Nuvi-Detox and Nuvi-JointRx products, as required by CFR 111.453. 
 
We received your written response dated November 7, 2014, which indicates that you planned to establish holding and distribution procedures on or before December 31, 2014. Your response is inadequate in that you did not provide further supporting documentation of the written procedures for your holding and distribution operations.   
 
9.    You failed to establish and follow written procedures for packaging and labeling operations of your EDTA Oral Chelation Nuvi-Detox and Nuvi-JointRx products, as required by 21 CFR 111.403.
 
We received your written response dated November 7, 2014, which indicates that you planned to establish written procedures for your re-labeling operations on or before December 31, 2014. Your response is inadequate in that you did not provide further supporting documentation of the written procedures for your labeling operation. 
 
10.   You failed to establish written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, including the review and investigation of product complaints, as required by  21 CFR 111.560, for your EDTA Oral Chelation Nuvi-Detox and Nuvi-JointRx products. 
 
We received your written response dated November 7, 2014, which indicates that you planned to establish written procedures for handling complaints related to your dietary supplements on or before December 31, 2014. Your response is inadequate in that you did not provide further supporting documentation of your written procedures for handling product complaints.  
 
The above violations are not intended to be an all-inclusive list of violations that exist 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 complies with all requirements of federal law and FDA regulations. Failure to take prompt action to correct the above violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the date by which you will have completed the corrections.
 
Your response should be directed to Melissa I. Michurski, Compliance Officer, at the address listed above. You can contact Ms. Michurski at (612) 758-7185 with any questions regarding this letter.
 
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District

Page Last Updated: 06/15/2015
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