Inspections, Compliance, Enforcement, and Criminal Investigations

Nexagen, LLC 10/6/17

 

  

Black HHS-Blue FDA Logo

 

Atlanta District Office
60 Eight Street, N.E.
Atlanta, GA 30309 

 
 

 

October 6, 2017
 
 
VIA UPS OVERNIGHT DELIVERY
 
Mr. Samuel Hong, CEO
Nexagen, LLC
115 Bethea Rd., Ste. 203
Fayetteville, GA 30214-7917
 
 
WARNING LETTER
(17-ATL-13)
 
Dear Mr. Hong,
 
From April 3 through April 7, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facilities located at 630 Highway 314, Ste. 1011, Fayette, GA 30214 and 115 Bethea Road, Ste. 203, Fayetteville, GA 30214. Our inspection revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111).  These violations cause dietary supplement products manufactured at your firm 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 conditions that do not meet the current good manufacturing practice regulations for dietary supplements found under 21 CFR Part 111. You may find the Act and FDA regulations through links on FDA’s homepage at www.fda.gov.
 
During the inspection, our FDA investigators observed the following significant violations of the CGMP regulations for dietary supplements:
 
1.    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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, your firm lacks written procedures for quality control operations. Once you have established your quality control written procedures, you must implement quality control operations into your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65; and you must implement a system of production and process controls to ensure the quality of the dietary supplements and that the dietary supplement is packaged and labeled as specified in a master manufacturing record, as required by 21 CFR 111.55.  
 
We have reviewed your response dated April 27, 2017. In your response, you stated that you will recruit and hire appropriate and qualified staff to assist in the role and responsibilities of the quality control unit. We are unable to evaluate the adequacy of your corrective action because you have not provided documentation of your written procedures for the responsibilities of the quality control operations.
 
2.    You failed to establish a specification for a 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). Specifically, you failed to establish any such specifications. The specifications you must establish include, but are not limited to, the following?
 
a.  Specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
b.  In-process production specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements, as required by 21 CFR 111.70(c).
c.  Specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d).
d.  Product specifications 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, as required by 21 CFR 111.70(e).
e.  Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).
 
Once you have established the required specifications, you must determine whether the specifications have been met in accordance with 21 CFR 111.73 and 21 CFR 111.75, and you must collect representative samples of each unique lot of components, packaging, and labels that you use to determine whether the components, packaging and labels meet specifications established in accordance with 21 CFR 111.70(a), (b), and/or (d), as applicable, as required by 21 CFR111.80(a).
 
We have reviewed your response dated April 27, 2017. We are unable to evaluate the adequacy of your corrective action because you did not provide evidence that you have established the required specifications. In your response, you stated that you will create a Vendor Self-Evaluation Questionnaire that will be submitted to all existing and new vendors to determine the supplier’s suitability and compliance standards; however, it is unclear how a Vendor Self-Evaluation Questionnaire would establish the specifications required under 21 CFR 111.70. Your response also stated that you will hire a GMP consultant to assist your quality control manager to establish product specifications and the appropriate policies in regards to the labels and packaging requirements, and that you intend to have the product specifications and policies completed and in place by the end of Q3 2017. However, you have not provided documentation of such product specifications and policies. 
 
3.    Your firm's master manufacturing record (MMR) failed to identify specifications for the 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 your MMR, as required by 21 CFR 111.205(b)(1). Specifically, the MMR for your Active Alliance Nutrition Fat Burner Extreme, Revive Fat Burner Peach Tea, Doomsday Skittles, Blood Shot Flagship Pre-Workout Complete (blackberry lemonade and popsicle), and Rupture Ultimate Power & Pump Pre-Workout (fruit punch and green apple) failed to identify all required specifications. In establishing MMRs, you must establish specifications that include, but are not limited to, the following:
 
a.  Specifications for each step, point 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 111.210(h)(1).
b.  Procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2).
c.  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).
d.  Corrective action plans for use when a specification is not met, as required by 21 CFR 111. 210(h)(5).
 
When you establish the required specifications in your MMRs, you must also establish controls and procedures to ensure that each batch of dietary supplements that you manufacture meets the specifications identified, as required by 21 CFR 111.205(b)(2).
 
We have reviewed your response dated April 27, 2017. In your response, you stated that you will hire a GMP consultant to assist in updating your MMRs. We are unable to evaluate the adequacy of your corrective action because you have not provided documentation of your updated MMRs.
 
4.    Your batch production records (BPRs) failed to include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, the batch production records (BPRs) did not include the following required information:
 
a.  The identity of the equipment used in producing the batch, as required by 21 CFR 111.260(b);
b.  An actual or representative label or a cross-reference to the physical location of the actual or representative label specified in the MMR, as required by 21 CFR 111.260(k)(2).
 
Once you have updated your MMRs, your updated BPR must accurately follow the appropriate MMR, and you must perform each step in the production of the batch, as required by 21 CFR 111.255(c). Your revised BPR must include all the applicable requirements as per 21 CFR 111.260.
 
We have reviewed your response dated April 27, 2017. In your response, you stated that you will hire a GMP consultant to assist in updating your BPRs. We are unable to evaluate the adequacy of your corrective action because you have not provided documentation of your corrective actions.
 
5.    Your firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you did not have any written procedures for when a returned dietary supplement is returned, including procedures for identifying, holding, evaluating, and disposing of returned products.
 
Once you have established such procedures, you must keep records for returned dietary supplements, as required by 21 CFR 111.535(b).
 
We have reviewed your response dated April 27, 2017. In your response, you stated that you will work with a GMP consultant to create, document, and train staff on comprehensive returns and recall policy by the end of Q3 2017. We are unable to evaluate the adequacy of your response because you have not provided documentation of your corrective actions.
 
6.    You failed to establish 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 failed to establish any written procedures for product complaints. Once you have established the procedures as required by 21 CFR 111.553 and 21 CFR 111.560, you must make and keep a written record of every product complaint, as required by 21 CFR 111.570.
 
We have reviewed your response dated April 27, 2017. In your response, you stated that you will work with a GMP consultant to create, document, and train staff on a comprehensive policy for product complaints by the end of Q3 2017. We are unable to evaluate the adequacy of your corrective action because you did not provide documentation to show that you have established the required written procedures.
 
7.    You failed to quarantine components before you used them in the manufacture of a dietary supplement, as required by 21 CFR 111.155(c).  Specifically, you failed to satisfy the specific requirements to quarantine components in 21 CFR 111.155(c).
 
We have reviewed your response dated April 27, 2017. In your response, you stated that you will immediately quarantine raw materials upon arrival until verification process to approve for use. We are unable to evaluate the adequacy of your corrective action because you have not provided supporting documentation of your corrective actions.
 
8.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have no written procedures for the distribution of your dietary supplement products. Once you establish written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
 
We have reviewed your response dated April 27, 2017. In your response, you stated that you will work with the GMP consultant to establish a proper written procedure for the distribution of manufactured products by the end of Q3 2017. We are unable to evaluate the adequacy of your corrective action because you did not provide evidence that you have established the written procedures.
 
The violations cited in this letter are not intended to be an all-inclusive statement 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 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.
 
You should take prompt action to correct all of the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including without limitation, seizure and injunction.
 
Additionally, we have the following comment. During the inspection, our investigators noted that in the past you have manufactured products which contain 1,3-dimethylamylamine, which will be referred to in the rest of this letter as “DMAA.” DMAA does not qualify as a dietary ingredient under section 201(ff)(1) of the Act because it is not a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any aforementioned substance.  Rather, DMAA is an unsafe food additive. 
 
If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, [1] it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act.
 
Section 201(s) of the Act [21 U.S.C § 321(s)] exempts dietary ingredients used in dietary supplements from the food additive definition. However, non-dietary ingredients intended for use in dietary supplements, such as the DMAA that you previously used in your dietary supplement products, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods. In other words, a non-dietary ingredient added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for its intended use, unless it qualifies for another exception to the food additive definition.
 
DMAA is not generally recognized as safe under its conditions of use in your dietary supplement products. Because DMAA does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, dietary supplements containing DMAA are adulterated under section 402(a)(2)(C)(i) of the Act because they contain an unsafe food additive.
 
We note that during the inspection you destroyed the bulk DMAA present in your firm and stated that you stopped manufacturing DMAA containing products in April of 2017.
 
You should notify this office in writing within 15 working days of receipt of this letter of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent recurrence of violations and provide related documentation for review and evaluation. If you are unable to complete correction actions within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
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 determining 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.
 
Your written response should be sent to Patricia F. Hudson, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, N.E., Atlanta, GA 30309. If you have any questions regarding this letter, please contact Patricia F. Hudson at 404-253-2221 or patricia.hudson@fda.hhs.gov.
 
Sincerely,
/S/ 
Ingrid A. Zambrana
District Director
U.S. Food & Drug Adminisration
FDA Atlanta District
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
Office of Regulatory Affairs


[1] Under section 201(s) of the FD&C Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.

 

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