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WARNING LETTER

Txsyn Int. LLC MARCS-CMS 677014 —

Delivery Method:
Via Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Mark A. Rivera
Recipient Title
Chief Operations Manager/Co-Owner
Txsyn Int. LLC

7232 Eckhert Rd Ste 7234
San Antonio, TX 78238-1244
United States

mark@txsynlabs.com
Issuing Office:
Division of Human and Animal Food Operations West III

United States

July 24, 2024

WARNING LETTER
CMS #677014

Dear Mr. Rivera:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 7232 Eckhert Rd., Ste 7234, San Antonio, TX 78238-1244 on October 25 – November 14, 2023. Based on inspectional findings, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. You can find the Act and FDA regulations through links in FDA's home page at www.fda.gov.

At the conclusion of the inspection on November 14, 2023, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated December 12, 2023, January 16, 2024, and January 19, 2024, and we address your responses below.

Adulterated Dietary Supplements

The inspection of your facility on October 25 through November 14, 2023 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 your dietary supplements to be adulterated within the meaning of section 402(g)(1) of 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 requirements are as follows:

1. You did not retain reserve samples for the required time for use in appropriate investigations, as required by 21 CFR 111.465(b). Specifically, during the inspection, you told our investigator that you retain reserve samples of your repacked dietary supplement products for a period of (b)(4). Under 21 CFR 111.465(b), you must retain reserve samples for one year past the shelf-life date (if shelf-life dating is used), or for two years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations.

We received and reviewed your responses dated December 12, 2023, January 16, 2024, and January 19, 2024. In your response to this observation, dated January 16, 2024, you stated that “[w]e corrected and labeled retention samples before the end of our inspection” and “[w]e have a special location for retention samples and hold for are [sic] required to hold for 2 years for the lot.” However, you did not provide any supporting documentation demonstrating you made these corrections. Further, the inspector did not observe any corrections prior to the closeout of the inspection. Consequently, we cannot evaluate the adequacy of your corrections at this time.

2. You did not establish and follow written procedures for fulfilling the requirements of 21 CFR Part 111, Subpart G for product you receive for packaging or labeling as a dietary supplement, as required by 21 CFR 111.153. Specifically, during the inspection, you did not have any procedures in place for the dietary supplement products you receive for packaging and labeling, such as your THINK BOTANICALS IMMUNITY MUSHROOM gummy product. You repackage, label, and distribute the product, including Lot (L) 01-7314, distributed on 7/31/23.

We received and reviewed your responses dated December 12, 2023, January 16, 2024, and January 19, 2024. In your response to this observation, dated January 16, 2024, you stated that “[w]e updated the label to be in compliance.” On January 19, 2024, you provided a document titled “Inbound Policy.” To the extent you intend for this document to be your written procedures for fulfilling the requirements of 21 CFR Part 111, Subpart G, they do not. For example, your "Inbound Policy" failed to provide written procedures regarding the examination of each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product, as required by 21 CFR 111.165(a).

3. You did not establish and follow written procedures to fulfill the requirements related to your packaging and labeling operations, as required by 21 CFR 111.403. Specifically, during the inspection, our investigator requested these procedures, and you said that your company does not have any procedures in place for packaging and labeling operations for the dietary supplement products you receive for labeling, such as your THINK BOTANICALS IMMUNITY MUSHROOM gummy product. You repackage, label, and distribute the product, including Lot (L) 01-7314, distributed on 7/31/23.

We received and reviewed your responses dated December 12, 2023, January 16, 2024, and January 19, 2024. In your response to this observation, dated January 16, 2024, you provided a blank “PACKAGING DESIGN CHECKLIST (poly, carton)” and a “Pre-Operation Procedure.” In another response dated January 16, 2024, you also provided a “Standard Operating Procedure (SOP) for GMP Clean Room: Repackaging of Bulk Products.” However, these documents do not cover all the applicable requirements of 21 CFR Part 111, Subpart L for written procedures for packaging and labeling operations. For example, none of these documents provide written procedures for the examination, before packaging and labeling operations, of packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the master manufacturing record, as required by 21 CFR 111. 410(c). Likewise, none of these documents provide written procedures regarding the examination of a representative sample of each batch of repackaged or relabeled dietary supplements to determine whether the repackaged or relabeled dietary supplements meet all specifications established in accordance with 21 CFR 111.70(g), as required by 21 CFR 111.420(b).

4. You did not establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, during the inspection, our investigator found that you do not have any procedures in place for the handling of returned dietary supplements, to include the identification and quarantine of the products until quality control personnel conduct a material review and make a disposition decision.

We received and reviewed your responses dated December 12, 2023, January 16, 2024, and January 19, 2024. In your response to this observation, dated January 16, 2024, you stated “[t]his was a new product, and only a few samples of all products were released”; “[w]e are following the current process to control the release of new products”; and “[w]e have established a QA Hold program with a disposition for product.” You also provided a copy of your “QA Hold Procedure.” However, your “QA Hold Procedure” does not appear to cover returned dietary supplements. Rather, it applies to “nonconforming products and materials detected by Txsyn.” Accordingly, we cannot evaluate the adequacy of your corrections at this time because you did not provide for review any written procedures for the receipt and disposition of a returned dietary supplements.

5. Your quality control personnel failed to approve the received product for packaging or labeling as a dietary supplement before releasing the received product from quarantine, as required by 21 CFR 111.165(c)(3). Specifically, you received the dietary supplement THINK BOTANICALS IMMUNITY MUSHROOM gummy product from (b)(4) on (b)(4), (b)(4), under invoice number (b)(4). You repackaged, labeled, and released the product for distribution on 7/31/23 without approval by quality control personnel.

We received and reviewed your responses dated December 12, 2023, January 16, 2024, and January 19, 2024. In your response to this observation, dated January 16, 2024, you stated “[t]his was a new product; only a few samples were released.” You also provided an “Inbound Policy” and “Incoming Product Inspection” sheet, which appear to provide for quality control review prior to releasing dietary supplements from quarantine. We will assess the adequacy of your corrections during the next inspection.

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.

Please notify FDA in writing, within 15 working days of 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 the recurrence of 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.

Your written response should be sent to René R. Ramirez, Compliance Officer, U.S. Food and Drug Administration, 1201 North Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Ramirez at rene.ramirez@fda.hhs.gov or (210) 308-1425.

Sincerely,
/S/

Edmundo Garcia, Jr.
Program Division Director HAF West 3

Cc: Amir Ajani, CEO
Txsyn Int. LLC
7232 Eckhert Rd Ste 7234
San Antonio, TX 78238-1244 US

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