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  5. Seven - 594867 - 03/11/2020
  1. Warning Letters

WARNING LETTER

Seven MARCS-CMS 594867 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Drugs
Food & Beverages
Recipient:
Recipient Name
Gabriel Costilla
Recipient Title
Owner
Seven

1420 Decision St., Ste. C
Vista, CA 92081-8576
United States

Issuing Office:

United States

WARNING LETTER

WL 594867

Dear Mr. Costilla:

The United States Food and Drug Administration (FDA) inspected your facility located at 1420 Decision St., Ste. C, Vista, CA on August 12-13, 15, and 19, 2019. The inspection revealed 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 the dietary supplement products manufactured at your facility 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. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

We have received your written response dated August 28, 2019, concerning the Form FDA 483, Inspectional Observations, which was issued to you on August 19, 2019. We address your response below in regard to the specific violations, which are as follows:

1. You failed to establish specifications required by 21 CFR 111.70. Specifically:

a. You failed to establish component specifications, as required by 21 CFR 111.70(b), for each component that you use in the manufacture of a dietary supplement, including for components of the Male Formula Blend, Energy Veg (also known as Extreme Energy), and Total Cleanse dietary supplements you manufacture. In particular, you did not establish an identity specification for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). You also did not establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).

Before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 11.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).

b. You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with dietary supplements, as required by 21 CFR 111.70(d). For example, during the inspection you stated that you have not established label and packaging specifications for the (b)(4) products you manufacture.

c. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). For example, during the inspection, our investigator observed that you did not have finished product specifications for the Male Formula Blend product that you manufacture.

Once you have established specifications, you must determine whether the specifications are met in accordance with 21 CFR 111.73, and you must make and keep records in accordance with 21 CFR 111.95(b).

We have reviewed your August 28, 2019 response, in which you stated (b)(4) component and finished product specifications for all dietary supplements that you manufacture. You also provided documents that you purport to be component and finished product specifications for your CHI‐206 product. However, these documents do not demonstrate that you have established finished product specifications for the purity and strength of the finished batch of the CHI-206 dietary supplement, or that you have established component specifications to ensure that specifications for the purity, strength, and composition of the finished CHI-206 product are met. Further, we are unable to evaluate the adequacy your corrective actions to address the noted violations because you did not provide specifications for any other dietary supplement you manufacture—including your Male Formula Blend, Energy Veg (aka Extreme Energy), Total Cleanse, Estro Strike 2.0, and Solluna (Detoxy) products.

2. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement 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). For example, during the inspection you did not have a written MMR for the Male Formula Blend or the Glucosamine with Chondroitin and MSM dietary supplements manufactured by your firm.

In addition, the written MMRs you were able to provide to our investigator failed to include information required by 21 CFR 111.210. Specifically, the MMRs you provided to our investigator for your Extreme Energy (aka Energy Veg) and Total Cleanse did not include the following:

a) A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made, as required by 21 CFR 111.210(f);
b) A description of packaging and, with respect to the Total Cleanse, a representative label, or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g); and
c) Written instructions, as required by 21 CFR 111.210(h), including the following:
  i. Procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2); and
  ii. Corrective action plans to use when a specification is not met, as required by 21 CFR 111.210(h)(5).

We have reviewed your response dated August 28, 2019, in which you (1) stated (b)(4) an MMR for each product you manufacture; and (2) included what you purport to be a written MMR for your CHI-206 product. However, we are unable to evaluate the adequacy of your corrective actions to address the noted violations because you did not include MMRs for the Male Formula Blend, Glucosamine with Chondroitin and MSM, Energy Veg (aka Extreme Energy), or Total Cleanse products. Moreover, the documents you provided for your CHI-206 product do not include all the information required under 21 CFR 111.210.

3. Your batch production records (BPRs) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. For example, during the inspection our investigator collected copies of your batch production records for the Energy Veg (aka Extreme Energy) and Solluna (Detoxy) dietary supplements that you manufacture, which did not include the following:

a) The identity of equipment and processing lines 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 capsule, packaging material, and label used, as required by 21 CFR 111.260(d).
d) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, such as after blending and after encapsulation, as required by 21 CFR 111.260 (f);
e) Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i); and
f) Documentation, at the time of performance, that quality control personnel (1) reviewed the BPR; and (2) approved and released, or rejected, the batch for distribution, as required by 21 CFR 111.260(l).

We have reviewed your response dated August 28, 2019, in which you (1) stated (b)(4) all your BPRs to include all the information required by 21 CFR 111.260; and (2) provided a copy of documents you purport to be the BPR for your CHI-206 product. However, the documents you provided do not include all of the information required by 21 CFR 111.260.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. 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, including FDA regulations.

You should take prompt action to correct 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.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

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 re-inspection related costs. A re-inspection 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 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.

Your written response should be directed to:

Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612

Refer to the Unique Identification Number CMS 594867 when replying.

If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations-West Division 5

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