MCACO, LTD

This is to advise you that the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1610 W. Polo Rd, Grand Prairie, TX from November 4, 2021, through December 7, 2021. Based on the inspectional findings we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

The inspection of your facility 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, Part 111 (21 CFR 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of 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. FDA acknowledges the receipt of your e-mail correspondence dated December 30, 2021, written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We address your response below, in relation to each of the noted violations.

The significant violations documented 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, as required by 21 CFR 111.70(e). Specifically, your finished product specifications for (b)(4) and (b)(4) fail to include established specifications for purity, strength, and composition for the dietary supplement products. When establishing such specifications, a list of tests or references to analytical procedures and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described should be included.

We acknowledge your response, received December 30, 2021, which acknowledged that specific elements needed to be updated and asserted that “[b]y March 31, 2022, MCACO will update and complete component specifications.” However, we are unable to evaluate the adequacy of your corrective action because you did not provide updated finished product specifications for review. Additionally, Appendix 2, which you appear to suggest included a copy of revised specifications, was not included in your response.

2. You failed to establish component specifications that are necessary to ensure specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, you have not established ingredient specifications to ensure the purity, strength, and composition of your (b)(4) (120 Capsules, Batch: (b)(4), manufactured on (b)(4)) and (b)(4) (60 capsules, Batch: (b)(4), manufactured on (b)(4)). When establishing such specifications, a list of tests, or references to analytical procedures and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described should be included.

We acknowledge your response received December 30, 2021, which states, “MCACO initiated an initial review of specifications of components. . .. By March 31, 2022, MCACO will complete the update of component specifications. By April 30, 2022, MCACO will ensure that all involved personnel are trained and updated on the new specification requirements for purchasing, receiving, and testing of components.” However, we are unable to evaluate the adequacy of your corrective action because you did not provide updated component specifications for our review.

3. You failed to qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, you received from your suppliers Turmeric Root Powder (Supplier Lot: (b)(4)) and Milk Thistle Seed Extract (Supplier Lot: (b)(4)) for use in your (b)(4), and Amla Powder (Supplier Lot: (b)(4)) and Beet Root Powder (Supplier Lot: (b)(4)) for use in your (b)(4), and relied on their Certificate of Analysis (COA) for microbiological testing and heavy metals without first establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations. Additionally, you have never conducted heavy metal and microbiological tests to confirm results provided by the supplier’s COA.

We acknowledge your response received on December 30, 2021, which states that you reviewed your procedure for Supplier Partnership Program (b)(4) and that you will update specific elements to document and establish the reliability of suppliers by March 31, 2022. You stated that by (b)(4), MCACO will set up a random testing method for verification of supplier components, which could be internal or external compared to the reported certificate of analysis of each supplier. You also stated that by (b)(4), MCACO will have completed all reliability of suppliers through additional testing as necessary to confirm and verify the results of supplier certificates. Your response also provided a document titled, “Supplier Partnership Program” as Appendix 2, Attachment 2. We are unable to evaluate the adequacy of your corrective actions because you did not provide documentation to support that you have qualified the results of your supplier’s certificate of analysis for you to be able to rely on their microbial and heavy metal results.

4. You failed to verify that the laboratory examination and testing methodologies are appropriate for their intended use, as required by 21 CFR 111.320(a). Specifically, your (b)(4) dietary supplement contains (b)(4), and (b)(4). You conduct infrared testing (IR) on the finished product, purportedly to confirm the identity and composition of the contents; however, the results of your IR tests do not identify the identity and composition of the contents encapsulated as the finished dietary supplement.

We acknowledge your response received December 30, 2021, which acknowledges that you do not have documentation of the testing methods used in certain documents, specifically for microbial testing and heavy metal testing. Your response states the tests performed were not documented on the specification’s sheets for components or finished product and that there was no documentation for the reasoning of using IR testing for identification of final product. You state that, on December 23, 2021, you reviewed and identified the policies, procedures and forms that were missing the testing method used for results, and that by (b)(4), you plan to have updated all the related documents (e.g., supplier partnership program, specifications of components, specifications of final product, Master Manufacturing Record, Batch production records and final product Certificates of Analysis) and that you will document the reason for using IR testing for identification. We are unable to evaluate the adequacy of your corrective actions because you did not provide documentation to verify that the laboratory examination and testing methodologies that you use are appropriate for their intended use.

5. You failed to establish master manufacturing records (MMRs) that include all required components of 21 CFR 111.210. Specifically, your master manufacturing records for (b)(4) (120 Capsules) and (b)(4) (60 Capsules) failed to include:

The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredient list of the dietary supplement [21 CFR 111.210(d)];

A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]; and

Written instructions, including specific actions necessary to perform and verify points, steps or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.210(h)(3)].

We acknowledge your response, received on December 30, 2021, in which you state you have reviewed a sampling of MMRs and determined that certain elements are missing including verification points. You also state that since production of various products is limited to (b)(4), you will ensure that elements in their MMRs are updated by (b)(4). We are unable to evaluate the adequacy of your corrective actions because you did not provide an updated MMR for review.

6. You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting standard reference materials used in performing test and examinations, as required by 21 CFR 111.315(d). Specifically, your Product Testing and Release Procedure ((b)(4)) states each time a component is analyzed it is added to the IR library as a reference standard. In accordance with your procedure, (b)(4) Batch (b)(4) was added to the IR library as a reference standard; however, your batch analysis does not include data to support that the batch was thoroughly characterized to ensure its identity, purity, quality, and strength. When using in-house or non-compendia reference standards, the batch should be prepared from a representative lot that is thoroughly characterized to be acceptable as a reference standard using appropriate testing methodologies.

7. You failed to ensure that the person who conducts a material review and makes the disposition decision, at the time of performance, documented that material review and disposition decision, as required by 21 CFR 111.113(c). Specifically, on November 4, 2021, your management provided our investigator a copy of the BPR for an unreleased batch of (b)(4) (60 capsules, Batch: (b)(4), manufactured on (b)(4)). On November 17, 2021, your management provided our Investigator a copy of the documentation relating to the same batch, except that the November 17, 2021, version of the BPR provided to our investigator had been completed and approved for release, signed, and dated September 29, 2021 (over a month before an unsigned and undated version of this document was first provided to our investigator). The documentation for this batch demonstrates that the documentation of the material review and disposition decision was not made at the time of performance. Additionally, note that 21 CFR 111.260(m) requires documentation at the time of performance any required material review and disposition decision. The expectation is that you will accurately document the current date at the time of the review and disposition.

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 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 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 response should be sent to Dana Lewis, Compliance Officer, U.S. Food and Drug Administration at the following email: dana.lewis@fda.hhs.gov (preferred) or you may mail a hard copy, addressed to Dana Lewis, Compliance Officer, U.S. Food and Drug Administration at 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any further questions, please contact me at 214-253-5205 or by email.