The U.S. Food & Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 1730 Martin Luther King, Jr. Blvd, SE, Suite 6, Gainesville, GA 30504 from March 11 – 15, 2019. The inspection found that your facility has significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products you manufacture 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 the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a violation of section 301(a) of the Act.
You can find copies of the Act and pertinent 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 prepare and follow a written master manufacturing record for each unique formulation of a 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). Specifically, your firm has not established a written Master Manufacturing Record for all dietary supplement products including, but not limited to, “
(b)(4)
”, “
(b)(4)
”, and “
(b)(4)
.”
2. You failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, 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:
- Specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you must establish an identity specification; specifications to ensure purity, strength and composition of dietary supplements manufactured using the components are met; and specifications that establish the limits on those types of contamination that may adulterate or 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(b)(1)-(3).
- In-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements, as required by 21 CFR 111.70(c)(1).
- Specifications for dietary supplement labels and for packaging that may come in contact with the dietary supplements, as required by 21 CFR 111.70(d).
- Specifications for each dietary supplement that you manufacture 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 to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
- Specifications for the labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you applied the specified label, as required by 21 CFR 111.70(g).
Once you have established component specifications and 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 111.75(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 also 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).
Further, once you have established specifications, you must determine whether they are met in accordance with 21 CFR 111.73 and 111.75. You must also ensure any tests and examinations 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 all activities relating to such specifications in accordance with 21 CFR 111.95.
3. Your batch production record did not include complete information relating to the production and control of each batch and did not include all information required in a batch production record, as required by 21 CFR 111.255(b) and 111.260. Specifically, documents submitted as Batch Production Records for dietary supplement product “
(b)(4)
” do not include all required information relating to the production and control of each batch. Specifically, the record failed to include:
- 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).
- The identity and weight or measure of each component used, as required by 21 CFR 111.260(e).
- A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f).
- The actual results obtained during any monitoring operation, as required by 21 CFR 111.260(g).
- 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).
- Documentation, at the time of performance, of the manufacture of the batch, as required by 21 CFR 111.260(j). Specifically, you did not document encapsulation, bottling, packaging and labeling operations. These steps must be documented with the following information:
- The initials of the person responsible for weighing or measuring each component used in the batch, as required by 21 CFR 111.260(j)(2)(i).
- The initials of the person responsible for verifying the weight or measure of each component used in the batch, as required by 21 CFR 111.260(j)(2)(ii).
- The initials of the person responsible for adding the component to the batch, as required by 21 CFR 111.260(j)(2)(iii).
- The initials of the person responsible for verifying the addition of components to the batch, as required by 21 CFR 111.260(j)(2)(iv).
- Documentation, at the time of performance, of packaging and labeling operations, as required by 21 CFR 111.260(k), including:
- The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and reconciliation of any discrepancies between issuance and use of labels, as required by 21 CFR 111.260(k)(1).
- 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).
- Documentation at the time of performance that quality control personnel reviewed the batch production record, including any monitoring operation and the results of any tests and examinations on the finished batches of dietary supplements, and approved and released the batch and the packaged and labeled dietary supplements, as required by 21 CFR 111.260(l).
4. You did not hold components, dietary supplements, and labels under conditions to prevent their mix-up, contamination, or deterioration as required by 21 CFR 111.455(c). Specifically, during the inspection, the investigators observed dietary supplement ingredients and in-process materials being stored in various locations throughout your facility that that could lead to a mix-up or contamination of the product. Specifically, the investigators observed the following storage conditions:
- Labels for finished dietary supplement product “(b)(4)” were observed to be draped over various bins of supplements and records.
- Dietary supplement products “(b)(4)”, “(b)(4)”, and “(b)(4)” were observed to be stored intermingled with sealed, packaged, and unlabeled product.
- Pouches of dietary supplement product (b)(4) brand (b)(4) were stored in a bin which contained opened product Bulk Supplements brand “(b)(4).”
- Two large bags containing components identified by your firm’s owner as capsules were observed to be stored directly on top of postal mail packaging material. These bags were not labeled or identified in any manner.
5. You failed to identify and quarantine returned dietary supplements until quality control personnel conducted a material review and made a disposition decision as required by 21 CFR 111.510. Specifically, during the inspection, we observed a box that you informed the investigators was a returned finished product. This box was not identified as returned or held in quarantine. Furthermore, you also informed us, at the time of the inspection, that there was no quarantine area.
6. You failed to hold reserve samples of dietary supplements using the same container-closure system in which the packaged and labeled dietary supplement was distributed as required by 21 CFR 111.83(b)(1). Specifically, you do not collect reserve samples of finished dietary supplement products. You collect samples of powder mixture prior to encapsulation, bottling, and labeling operations and store them in a clear plastic bag.
7. You did not make and keep records of the written procedures for the packaging and labeling operations as required by 21 CFR 111.430(b). Specifically, you have not established written procedures for packaging and labeling operations. Furthermore, you informed the investigators that the packaging and labeling operations for finished dietary supplement products are not documented in any manner.
8. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distribution operations and you do not document batch numbers or unique identifiers for dietary supplement products distributed by your firm.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 you comply with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in legal action without further notice, including, without limitation, seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you believe that the products you manufacture are not in violation of the FD&C 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 the 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 determine 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, the FDA may assess fees to cover any reinspection-related costs.
