WARNING LETTER
Healthtex Distributors, Inc.
MARCS-CMS 654453 —
June 15, 2023
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Natividad R. Elias
Recipient Title
President and Owner
Healthtex Distributors, Inc.
3555 NW 41st St
Miami
,
FL
33142-4310
United States
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Secondary Issuing Offices
United States
06/15/2023
WARNING LETTER
23-HAFE4-WL-04/CMS No. 654453
CC: Ms. Yvette C. Barreto, Vice president, and Chief Finance Officer (CFO)
Dear Ms. Elias,
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement warehouse and distribution facility, located at 3555 NW 41st St, Miami, Florida, on January 24, 2023, January 25, 2023, and February 1, 2023. The inspection revealed serious violations of FDA’s regulation 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 supplement products 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 CGMP requirements for dietary supplements. We also reviewed your product labeling we collected during the inspection, and found serious violations under Title 21, CFR Part 101, which render your Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water dietary supplement products misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
We received your correspondence sent electronically on February 22, 2023 concerning our inspectional observations listed on the FDA-483, Inspectional Observations, issued to you at the close of the inspection. We address this response below as it relates to the noted observations.
Adulterated Dietary Supplements
Your dietary supplement products are adulterated dietary supplements under 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 regulations for dietary supplements. During the inspection, FDA investigators observed the following significant violations of CGMP regulations for dietary supplements:
1. You did not 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, as required by 21 CFR 111.103, and you did not implement quality control operations, including quality control operations for a material review and disposition decision, as required by 21 CFR 111.113. Specifically, during the inspection, you did not have any written procedures for quality control operations for the dietary supplements you own and distribute. Also, during the inspection, our investigators observed that your firm does not perform any quality control operations for your finished dietary supplements, Dr. Sana brand Cod Liver Oil and Dr. Sana brand Orange Blossom Flower Water, to include approving and releasing products for distribution.
We have reviewed your response, dated February 22, 2023, which included a procedure, “
(b)(4)
,” and your “
(b)(4)
.” These documents assign the product receiving responsibility to the Purchasing Department, including the review of shipment documentation. However, neither document provides your firm’s quality control procedures for dietary supplement products, such as written procedures for conducting a material review and making a disposition decision in accordance with 21 CFR 111.113, including products contract manufactured for your firm’s own label.
2. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection, you stated that you do not have holding and distribution written procedures.
We have reviewed your response, dated February 22, 2023. Your response included a procedure titled “
(b)(4)
.” This procedure does not address all the requirements under 21 CFR 111, Subpart M. For example, your Dr. Sana brand Cod Liver Oil and your Dr. Sana brand Orange Blossom Flower Water dietary supplement finished product labels list storage temperatures, but your procedure does not include instructions on how to appropriately store these products based on the storage temperatures indicated on the product labels. Per 21 CFR 111.455(a), you must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected.
3. You failed to identify who is responsible for your quality control operations, as required by 21 CFR 111.12(b). Specifically, you did not identify any individual(s) to be responsible for your quality control operations.
Once you identify individual(s) to perform quality control operations, each person must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations (21 CFR 111.12(b)).
Misbranded Dietary Supplements
In addition, your Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water products are misbranded dietary supplements under 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 101 as follows:
1. Your Dr. Sana Cod Liver Oil product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual name of each ingredient in accordance with 21 CFR 101.4(g). Specifically, the manufacturing records you provided to our investigator regarding Dr. Sana Cod Liver Oil, lot number 220528, demonstrate the product contains Vitamin E and mineral oil as ingredients. These ingredients are not declared on the finished product’s label.
In addition, your Dr. Sana brand Orange Blossom Flower Water 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 declares Orange Blossom Flower Water as an ingredient. The batch production record for the product declares the ingredient Orange Blossom Distillate Flower Water which is fabricated from two or more ingredients. The ingredient list fails to declare the individual ingredients that make up the Orange Blossom Distillate Flower Water as required by 21 CFR 101.4(a) and (g).
2. Your Dr. Sana brand Cod Liver Oil and your Dr. Sana brand Orange Blossom Flower Water dietary supplement products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in two languages but does not repeat all of the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The product includes foreign language on the label but fails to declare all subsequent information in the Supplements Facts label in both languages as required.
3. Your Dr. Sana Cod Liver product is 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,
• Calories per serving fails to be declared in accordance with 21 CFR 101.36(b)(2) and 101.9(c).
• Total fat per serving fails to be declared in accordance with 21 CFR 101.36(b)(2) and 101.9
• Vitamin D per serving fails to be declared in accordance with 21 CFR 101.36(b)(2) and 101.9(c).
4. Your Dr. Sana brand Cod Liver Oil and Dr. Sana brand Orange Blossom Flower Water products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
5. Your Dr. Sana brand Orange Blossom Flower Water product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
6. Your Dr. Sana brand Orange Blossom Flower Water product is 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.
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 fifteen (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 fifteen (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 directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, Program Division Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernández
Program Division Director
Office of Human and Animal Food Operations
East IV Division
Content current as of:
03/05/2024
Regulated Product(s)
Dietary Supplements