From February 11 to February 15, 2019, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 696 S 5300 W, Hurricane, Utah. The inspection revealed serious violations of 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)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You may find the Act and FDA regulations through links on FDA’s website at
www.fda.gov
.
We acknowledge receipt of your responses, one dated March 7, 2019 and one received on April 16, 2019, to the Form FDA 483, Inspectional Observations, issued to you on February 15, 2019, and we address your responses after the applicable violations, noted below.
The significant violations of CGMP requirements observed during the inspection include, but are not limited to, the following:
1. 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 (b)(4) and (b)(4) products that you manufacture.
We have reviewed your March 7, 2019 and April 16, 2019 responses, but we are unable to evaluate the adequacy of your corrective actions. In your April 16, 2019 response, you provided copies of the “Batch Sheets” from the Master Manufacturing Records (MMRs) for your (b)(4) and (b)(4) products and indicated that these are “one of the specifications for the finished products [i]dentity.” However, these sheets do not demonstrate that you have established finished batch specifications for the identity, purity, strength, composition, and limits on contaminants for the finished batch of dietary supplement.
2. 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. Specifically, you 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). For example, you have not established component specifications for the purity, strength, and composition of your (b)(4)%, (b)(4), and (b)(4). We also note that you must establish an identity specification for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1); however, the documents you purport to use as your specifications list organoleptic characteristics for identity, such as “appearance/color” and “odor/taste,” which alone are not sufficient to determine the identity of these components. In addition, you include “characteristic” as the specification for “odor/taste” for your (b)(4) and (b)(4) components, without offering any specifics on the odor and/or taste of the component.
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 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).
We have reviewed your March 7, 2019 and April 16, 2019 responses, but we are unable to evaluate the adequacy of your corrective actions. The documents that you purport to be component specifications in your April 16, 2019 response, including those you provided for (b)(4) and (b)(4), do not demonstrate that you have established specifications for purity, strength, and composition of the component that are necessary to ensure that specifications for the purity, strength and composition of the dietary supplements manufactured using the components are met.
3. Your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). For example, your finished product specifications for your (b)(4) product (also referred to as your (b)(4) product), labeled as (b)(4), were not signed and approved by your firm’s quality control personnel.
We have reviewed your March 7, 2019 and April 16, 2019 responses, but we are unable to evaluate the adequacy of your corrective actions. While your April 16, 2019 response indicates that “quality personnel [is] going through each MMR” and “the blended batch needs to be approved by Quality,” your response does not provide documentation demonstrating approval or rejection all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement by your firm’s quality control personnel.
4. Your batch production record (BPR) 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. Specifically, your batch production records for (b)(4) (lots (b)(4) and (b)(4)), (b)(4) (lot (b)(4)) and (b)(4) (lot (b)(4)) did not include the following required information:
- 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 longs, where this information is retained [21 CFR 111.260(c)]
- A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]
- The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)]
- Documentation, at the time of performance, that quality control reviewed the batch production record, and approved and released, or rejected, the batch and the packaged and labeled dietary supplements [21 CFR 111.260(l)]
We have reviewed your March 7, 2019 and April 16, 2019 responses, but we are unable to evaluate the adequacy of your corrective actions. Your April 16, 2019 response states “quality will determine if it meets the final specs and sign off on the Batch Production Records for the batch and will release it for shipment” and includes a blank MMR for your (b)(4) product. However, your response did not include documentation to demonstrate that you have prepared and implemented BPRs that include the required elements, including quality control review of BPRs and approval and release, or rejection of the batch for distribution and the packaged and labeled dietary supplements.
5. You did not control the issuance and use of labels, as required by 21 CFR 111.410(b). Specifically, your firm applies labels to the dietary supplements you manufacture; however, you do not have a system for controlling the issuance and use of labels.
We have reviewed your March 7, 2019 and April 16, 2019 responses, but we are unable to evaluate the adequacy of your corrective actions because you did not address any corrective actions related to this observation.
6. You did not make and keep documentation of the date of use, maintenance, cleaning, and sanitizing of equipment, and documentation of any calibration, each time the calibration is performed, for instruments used in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(2) and (b)(3). Specifically, our investigator observed that your sanitation logs for your equipment, including your (b)(4), (b)(4), (b)(4), and (b)(4) encapsulator that are actively being used in the manufacturing of dietary supplements, did not contain any data or recorded dates, or had not been updated since 2017 or 2018, for when sanitation had occurred; however, you stated that you have cleaned and sanitized without documenting. Furthermore, during the inspection, our investigator observed that you use scales in your batching rooms to measure ingredients used in the manufacturing of your dietary supplements; however, you stated that you did not have documentation of scale calibrations, even though such calibration is required by your firm’s written “Scale Verification” standard operating procedure.
We have reviewed your March 7, 2019 and April 16, 2019 responses, but we are unable to evaluate the adequacy of your corrective actions because you did not address any corrective actions related to these observations.
7. You did not make and keep documentation of training, as required by 21 CFR 111.14(b)(2). Specifically, your firm performs manufacturing, labeling, and quality control operations; however, during the inspection you stated that you do not document employee training.
We have reviewed your March 7, 2019 and April 16, 2019 responses, but we are unable to evaluate the adequacy of your corrective actions because you did not address any corrective actions related to this observation.
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.
In addition, we offer the following comments:
- Your firm uses organoleptic analysis as a method of testing for determining whether your component and/or finished batch specifications are met. However, to the extent that you use organoleptic analysis, your method of testing or examination for determining whether the specifications are met must be appropriate and scientifically valid methods, as required by 21 CFR 111.75(h). We note that, while FDA recognizes that gross organoleptic analysis is an acceptable method, organoleptic analysis may not be an appropriate method of testing for certain substances. This is particularly true when the nature of the substance decreases the reliability of organoleptic analysis. For example, while organoleptic analysis may be an appropriate identity test for whole or coarsely‐cut botanical parts, it may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur [72 Fed. Reg. 34752 at 34852, June 25, 2007].
- Your written procedures are identified with a different company name and should be under your current firm name. In addition, these procedures include handwritten changes which do not appear to be a part of the official written procedures.
Within fifteen (15) 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 actions within fifteen (15) 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.
