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  5. Absonutrix, LLC - 583992 - 08/26/2019
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WARNING LETTER

Absonutrix, LLC MARCS-CMS 583992 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements

Recipient:
Recipient Name
Himanshu Nautiyal
Recipient Title
CEO/President
Absonutrix, LLC

317 S. Westgate Dr., Suite L
Greensboro, NC 27407-1633
United States

Issuing Office:
Division of Human and Animal Food Operations East III

60 Eight Street, NE
Atlanta, GA 30309
United States


August 26, 2019

Reference: CMS Case # 583992

WARNING LETTER

Dear Mr. Nautiyal:

The United States Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 317 S. Westgate Dr., Suite L, Greensboro, NC from March 18-22, 2019. Additionally, our investigators collected and reviewed labeling for your products during the inspection of your facility. Based on our inspection and subsequent review of your product labels, we have found 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 homepage at www.fda.gov.

Adulterated Dietary Supplements

Our investigators observed significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 of the Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your products adulterated under 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 found in 21 CFR Part 111.

During the inspection, our FDA investigator observed the following significant violations of the CGMP regulations for dietary supplements:

1.    You failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you failed to verify the identity of raw ingredients ((b)(4) and (b)(4)), received on September 6, 2018, prior to use in manufacturing dietary supplement products. We note that since the previous inspection, your firm has implemented the use of a (b)(4) FT-IR and utilizes (b)(4) for identity testing for some dietary ingredients. However, since you failed to verify the identity of these raw ingredients, this is a repeat observation because you are required to conduct identity testing for all dietary ingredients received prior to use in manufacturing dietary supplements.

We have reviewed your response submitted April 3, 2019. We are unable to evaluate the adequacy of your corrective action, as documentation was not provided to demonstrate that the FT-IR test results confirmed the results of the supplier’s certificate of analysis.

2.    You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of your dietary supplements, 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 have not prepared a written MMR for Absonutrix brands Anti-Gray Advanced Hair Formula Dietary Supplement, Sleep Drops Dietary Supplement, and Memory Drops Dietary Supplement manufactured by your firm.

In addition, the written MMRs you were able to provide to our investigators failed to include information required by 21 CFR 111.210. Specifically, the MMRs you provided to our investigator for your Uridine ID # 0810181, NAD Power Booster, ID # 121818-1, and Lions Mane Mushroom Extract product, ID # 0111019-3, did not include all the information, as required by 21 CFR 111.210. For example:

• Written instructions, as required by 21 CFR 111.210(h), including the following:

1) Specifications for each 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 111.210(h)(1);
2) Procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2);
3) 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).

     i. Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component, as required by 21 CFR 111.210(h)(3)(i); and
     ii. For manual operations, as required by 21 CFR 111.210(h)(3)(ii); such specific actions must include:

          A. One person weighing or measuring a component and another person verifying the weight or measure, as required by 21 CFR 111.210(h)(3)(ii)(A); and
          B. One person adding the component and another person verifying the addition, as required by 21 CFR 111.210(h)(3)(ii)(B).

We have reviewed your response submitted April 3, 2019, in which you stated you have implemented a procedure to create a new MMR for each batch size produced for a specific product, effective immediately. However, your response did not include documentation of implementation of your new procedure, and you have failed to submit a sample MMR and Batch Production Record (BPR) as indicated in the response. Therefore, we are unable to evaluate the adequacy of your corrective action.

3.    You failed to include complete information relating to the production and control of each batch in your batch production record (BPR) every time you manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(b). Specifically, the batch production records for Absonutrix Anti-Gray Lot AS31819-2; ; Uridine Lot AS12418-3; NAD Power Booster Lot AS2719-2; and Lion’s ManeMushroom Extract Lot AS21819-1 failed to contain the following information for a batch record, as required in 21 CFR 111.260:

Regarding the Absonutrix Anti-Gray Lot AS31819-2; Uridine Lot AS12418-3; NAD Power Booster Lot AS2719-2; and Lion’s Mane Mushroom Extract Lot AS21819-1 products:

a. The identity of equipment used in producing the batch, as required by 21 CFR 111.260(b);
b. The 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, such as individual equipment logs, where this information is retained, as required by 21 CFR 111.260(c);
c. The unique identifier that you assigned to each component, packaging and label used, as required by 21 CFR 111.260(d);
d. Documentation, at the time of performance, of the manufacture of the batch, as required by 21 CFR 111.260(j).
e. Documentation at the time of performance that quality control personnel performed all requirements of 21 CFR 111.260(l).

Regarding the Absonutrix Anti-Gray Lot AS31819-2; and Lion’s ManeMushroom Extract Lot AS21819-1 products:

a. The identity and weight or measure of each component used, as required by 21 CFR 111.260(e).

Regarding the Absonutrix Anti-Gray Lot AS31819-2 product:

a. An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record, as required by 21 CFR 111.260(k)(2).

We note that observations related to incomplete BPRs were also identified in the November 11, 2017 through December 1, 2017 FDA inspection, and you still have not implemented corrective actions. We have reviewed your response submitted April 3, 2019. We are unable to evaluate the adequacy of the corrective actions identified in your response, as you have not submitted documentation to demonstrate that these actions have been implemented.

4. You did not make and keep documentation of calibrations for instruments or controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(3). Specifically, you did not have documentation of calibrations for equipment used in encapsulation, filling, labeling and packaging dietary supplements. Furthermore, you stated in a signed affidavit that you do not conduct any calibrations for equipment used during the manufacturing of dietary supplements. We note this is a repeat observation that has been identified in previous inspections without implementation of a corrective action.

We have reviewed your response submitted April 3, 2019. The response states that your company keeps records of daily calibrations of the machines operated; however, these records were not provided to the investigator during the inspection. Your response did not include any documentation that the equipment you are using to manufacture dietary supplement products has been calibrated.

Misbranded Dietary Supplements

Certain of your dietary supplement products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements, as required by 21 CFR Part 101, for the reasons discussed as follows:

1. Your Absonutrix Uridine 500 mg, Absonutrix NAD Power Booster, and Absonutrix Lions Mane Mushroom Extract products are 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 and misleading because the amount of the dietary ingredient present is less than the amount declared. Specifically:

• According to your Absonutrix Uridine 500 mg product’s MMR #0810181, the amount of uridine monophosphoric per capsule is (b)(4) mg, whereas the quantitative amount declared on the product’s Supplement Facts label is 500 mg per 1 capsule serving. Likewise, the principal display panel states “500 mg” under the product name Uridine, implying that is the amount of uridine in 1 capsule, which is false.

• According to your Absonutrix Lions Mane Mushroom Extract product’s MMR #011019-3, the amount of lion’s mane mushroom per capsule is (b)(4) mg, whereas the quantitative amount declared on the product’s Supplement Facts label is 500 mg per 1 capsule serving.

• According to your Absonutrix NAD Power Booster product’s MMR #121818-1, the total amount of the dietary ingredients nicotinamide riboside plus pterostilbene per unit (bottle) is (b)(4) mg. The label declares 120 servings per bottle; therefore, the amount of the dietary ingredients per serving is 50 mg, whereas the quantitative amount declared on the product’s Supplement Facts label is 300 mg per 1 dropperful serving.

2. Your Absonutrix NAD Power Booster product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to correctly declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Specifically, the product label lists the measure in fluid ounce in accordance with 21 CFR 101.7(b)(2) but fails to follow that measure with the metric equivalent as required by 15 U.S.C.§ 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA).

3. Your Anti-Grey Advanced Hair Formula product is 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 the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, your Anti-Grey Advanced Hair Formula product label declares the dietary ingredients PABA and nettle, but these are not the common or usual names for those dietary ingredients. PABA must be spelled out and nettle is not the standardized common name noted in the reference Herbs of Commerce.

In addition, your Absonutrix Lions Mane Mushroom Extract label declares Lion’s Mane Mushroom Complex. The term “complex” implies there is more than one ingredient, whereas the MMR indicates the only dietary ingredient is lion’s mane mushroom.

4. Your Absonutrix Memory Drops, Absonutrix Sleep Drops, Absonutrix NAD Power Booster, and Lyfetrition Vitamin B12 products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k) in that they contain chemical preservatives and the label fails to state that fact. Specifically, the labels fail to identify the function of chemical preservatives listed in the ingredients statement ((b)(4)) per 21 CFR 101.22(j).

5. Your Absonutrix Memory Drops, Absonutrix Sleep Drops, Absonutrix NAD Power Booster, and Absonutrix Uridine 500 mg product are misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the labels are incorrect or incomplete. 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:

• Your Absonutrix Memory Drops and Absonutrix Sleep Drops product labels’ Suggested Use states “take one dropperful,” whereas the serving size lists “30 Drops.” The serving size should be 1 dropperful.
• Your Absonutrix Memory Drops, Absonutrix Sleep Drops, and Absonutrix NAD Power Booster product labels fail to follow the common measure with the equivalent metric quantity as required by 21 CFR 101.9(b)(7).
• Your Absonutrix Uridine 500 mg product label’s “Suggested Usage” states, “take one (1) or two (2) vegetarian capsules daily,” but the serving size lists “1 Vegetarian Capsule.” The serving size listed should be two capsules.

6. Your Anti-Grey Advanced Hair Formula, Lyfetrition Vitamin B12, Absonutrix Memory Drops, Absonutrix Sleep Drops, Absonutrix NAD Power Booster, and Absonutrix Lions Mane Mushroom Extract 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 the nutrition information on the labeling does not comply with 21 CFR 101.36. For example,

• Your Anti-Grey Advanced Hair Formula product label lists folic acid. While this alternative name is an acceptable synonym for folate, the synonym must parenthetically follow the name of the nutrient in accordance with 21 CFR 101.36(b)(2)(i)(B)(2).
• Your Lyfetrition Vitamin B12 product label lists vitamin B-12 as part of a proprietary blend whereas (b)(2)-dietary ingredients contained in a proprietary blend must be declared separately in accordance with 21 CFR 101.36(b)(2). [21 CFR 101.36(c)(1)]
• Your Lyfetrition Vitamin B12 product label fails to declare the source of vitamin B12. The source of each dietary ingredient must be designated on the label in accordance with 21 CFR 101.36(d).
• Your Absonutrix Memory Drops, Absonutrix Sleep Drops, and Absonutrix NAD Power Booster product labels declare ingredients that appear to be part of a proprietary blend, but the labels fail to indent those ingredients under the term "Proprietary Blend" as required by 21 CFR 101.36(c)(2).

7. Your Absonutrix Memory Drops, Absonutrix Sleep Drops, and Absonutrix NAD Power Booster products are misbranded within the meaning of section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim; and the claim includes a mandatory disclaimer.

8. Your Lyfetrition Vitamin B12 and Absonutrix Uridine 500 mg 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).

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws and regulations. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and/or injunction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Section 743 of the Act, (21 USC 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 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 USC 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.

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, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If the corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Your written response should be sent to Patricia F. Hudson, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact Patricia F. Hudson at 404-253-2221 or email at patricia.hudson@fda.hhs.gov.


Sincerely,
/S/

Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3