The U.S. Food and Drug Administration (FDA) inspected your facility located at 4000 Dow Road, Suite #3, Melbourne, FL 32934 on 01/30/2019 to 02/05/2019 (dates not all inclusive). During the inspection, we found your firm had serious violations of Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
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 United States Code (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. In addition, the Desert Harvest Magnesium with Super-Strength Aloe Vera product that you manufacture is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. 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, our investigator issued a Form FDA 483, Inspectional Observations, listing the violations found at your firm. We acknowledge receipt of your firm’s written response dated 03/05/2019, addressing the violations conveyed to you at the conclusion of the inspection. Our review of your response is described below under each noted violation.
Adulterated Dietary Supplements
Your significant violations are as follows:
1. Your firm 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. Specifically:
- You failed to establish an identity specification for each component used in the manufacture of a dietary supplement as required by 21 CFR 111.70(b)(1). Specifically, your firm does not have identity specifications for components including, but not limited to, all botanicals, aloe vera, and (b)(4).
- You failed to establish component specifications that are necessary to ensure that the specifications for purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, your firm has not established component specifications for components including, but not limited to, all botanicals, aloe vera, and (b)(4).
- You failed to establish 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). Specifically, you have no product specifications for Desert Harvest Magnesium with Super-Strength Aloe Vera.
These are repeat observations from previous inspections of your facility that concluded on 04/25/2014 and 11/12/2015.
We have reviewed your written response dated 03/05/2019. You state that you have completed some previous testing of raw materials from one supplier and that you will establish specifications for identity, purity, strength, and composition of all finished products where your firm is the purchaser of all ingredients. Your response is inadequate because the requirements of 21 CFR 111.70 apply to all dietary supplement products manufactured at your facility, even if your firm is not the purchaser of all ingredients.
Once you have established the specifications identified above, you must verify that the specifications are met in accordance with 21 CFR 111.75(a), and you must make and keep records in accordance with 21 CFR 111.95(b). Your Quality Control Personnel must approve specifications, among other things, as required by 21 CFR 111.105(a).
2. You failed to qualify the suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, before using those components, as required by 21 CFR 111.75(a)(2)(ii)(A), and failed to maintain documentation of how the supplier was qualified, as required by 21 CFR 111.75(a)(2)(ii)(C). Specifically, your firm relies on suppliers’ certificates of analysis but did not qualify your suppliers for components including, but not limited to: all botanicals, aloe vera, magnesium stearate powder, and (b)(4), and you did not maintain any documentation of supplier qualifications. You stated that you previously attempted to qualify suppliers by sending out “Capability and Quality Surveys” to your component suppliers, but that you did not receive any responses. This is a repeat observation from the previous inspections that concluded on 04/25/2014 and 11/12/2015.
We have reviewed your written response dated 03/05/2019. Your response states that your firm completed some previous identity testing of raw materials from one supplier and that you will perform the necessary tests to qualify other suppliers. However, we are unable to evaluate the adequacy of your response because you have not provided documentation related to qualifying your suppliers of components other than dietary ingredients used in the formulation/manufacturing of finished dietary supplements.
Under 21 CFR 111.75(a)(2), you may confirm the identity of components other than dietary ingredients and determine whether other applicable component specifications established in accordance with 111.70(b) are met by conducting appropriate tests or examinations or by relying on a supplier’s certificate of analysis. In order to rely on a certificate of analysis, the following requirements of 21 CFR 111.75(a)(2)(ii) must be met:
- qualify the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations;
- the certificate of analysis must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations;
- maintain documentation of how you qualified the supplier;
- periodically re-confirm the supplier’s certificate of analysis; and
- the documentation setting forth the basis for qualification (and re-qualification) of any supplier must be reviewed and approved by quality control personnel.
3. You failed to prepare a written master manufacturing record 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). Specifically, your firm has not established and maintained written Master Manufacturing Records on file for each batch size of dietary supplement manufactured by your firm. You told the investigator during the inspection that you create an electronic master manufacturing record each time a batch is manufactured that is a different size than the previous batch by changing the capsule count, but that you do not save the new master manufacturing record for each batch size. This is a repeat observation from the previous inspection that concluded on 04/25/2014.
We have reviewed your written response dated 03/05/2019. You state that your firm will immediately start establishing and maintaining Master Manufacturing Records (MMR) for each batch of finished dietary supplements you manufacture. We are unable to evaluate the adequacy of your response because you have not provided copies of MMR for each unique formulation and each batch size of dietary supplements you manufacture.
4. You failed to provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(2). Specifically, you stated to our investigator that your in-process specification under 21 CFR 111.70(c)(1) for blending of raw materials in your (b)(4) in-process specification. However, when our investigators asked how (b)(4) was determined as the blending time to homogenize all mixtures of different bulk densities, you did not have any documentation to support this in-process specification for the dietary supplements you manufacture.
We have reviewed your written response dated 03/05/2019. You state that you will contact the blender manufacturer for blending studies and that you will select individual ingredients of different bulk densities and perform testing to determine the efficiency of the blending. We are unable to evaluate the adequacy of your response because you have not provided documentation of these studies.
5. Your firm’s batch production records (BPR) did not include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 111.260. Specifically, your firm’s BPR for the Desert Harvest Magnesium with Super-Strength Aloe Vera dietary supplement product did not include the following required information:
A. The identity and weight or measure of each component used [21 CFR 111.260(e)]. Specifically, the ingredient statement of the dietary supplement Desert Harvest Magnesium with Super-Strength Aloe Vera product label lists “(b)(4),” but these ingredients were not listed as components in the batch production record.
B. Documentation, at the time of performance, of packaging and labeling operations, including the unique identifier that you assigned to packaging and labels used and quantity used [21 CFR 111.260(k)(1)]. Specifically, you did not document the unique identifier that you assign to packaging and labels and the quantity used.
Misbranded Dietary Supplements
The Desert Harvest Magnesium with Super-Strength Aloe Vera product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the product label is false or misleading. Specifically, the label states that the product is “100% cGMP compliant.” This statement is false because, as described above, this product has not been manufactured in accordance with dietary supplement cGMPs.
The Desert Harvest Magnesium with Super-Strength Aloe Vera product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In accordance with 21 CFR 101.5(d), the statement of the place of business must include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
The Desert Harvest Magnesium with Super-Strength Aloe Vera 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 and labeling fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. For example, according to the batch production record, the product is formulated with (b)(4). However, neither of these ingredients is declared in the “other ingredients” list on the label. Further, the product label and the Desert Harvest website (
www.desertharvest.com
) labeling declares “a tiny amount of silicon dioxide” and “3 mg silicone dioxide as a drying agent …,” respectively but the batch production record does not indicate this ingredient as a component in the manufacture of the product. Finally, the product label lists “certified vegetable capsules” in the “other ingredients” list but does not declare the capsule ingredients in the list.
The Desert Harvest Magnesium with Super-Strength Aloe Vera product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). The product label fails to identify the part of the aloe vera used in the product.
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 have the following comment:
During the inspection we reviewed a batch production record for a product identified as “CBD/Hemp.” This product was in-process and awaiting a label from a customer. Without a label, it is unclear how this product is intended to be marketed. FDA has stated that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which CBD has been added. FDA has further stated that CBD products are outside the statutory definition of a dietary supplement. Finally, an unapproved new drug cannot be distributed or sold in interstate commerce. These statements, along with additional information about FDA regulation of cannabis-derived products, are available on our webpage:
https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm
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 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 the products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Additionally, 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 mean 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 foreign facility, FDA will assess and collect fees for re-inspection related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
