- Delivery Method:
- VIA UPS and Electronic Mail
- Dietary Supplements
Recipient NameJonathan Gillespie
- Muscle Feast, LLC
1320 Boston Road
Nashport, OH 43830
- Issuing Office:
- Office of Human and Animal Foods – East 5
July 22, 2022
Dear Mr. Gillespie:
This is to advise you that the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1320 Boston Road, Nashport, OH 43830 from December 13-15, 2021 to January 3-4, 2022. 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 in FDA's home page at 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 (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of 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.
FDA acknowledges the receipt of your e-mail correspondence dated January 18, 2022, 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.
Dietary Supplement CGMP Violations:
Your significant violations of CGMP requirements are as follows:
1. You failed to establish an identity specification for any of your components used in the manufacture of dietary supplements as required in 21 CFR 111.70(b)(1). Specifically, you have not established identity specifications for the ingredient caffeine anhydrous or other ingredients used in the product Muscle Feast MFX Pre Blue Ice Pop. You have also not established identity specifications for the ingredient whey protein isolate or other ingredients used in the product Muscle Feast ISOLATE Whey Protein Mocha Flavor.
2. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required in 21 CFR 111.70(b)(2). Specifically, you have not established component specifications to ensure the purity, strength, and composition for the ingredients: caffeine anhydrous, whey protein isolate, or other ingredients used in the products Muscle Feast MFX Pre Blue Ice Pop and Muscle Feast ISOLATE Whey Protein Mocha Flavor.
We have reviewed your January 18, 2022 response to the form FDA 483 and we note the following. The documents you provided do not establish standards to confirm the identify of the components you use in your dietary supplements. For example, the methods included in your documents are in part using High Performance Liquid Chromatography (HPLC) analysis. Identification by HPLC, described in your documents as “positive”, “conforms”, or “meets requirements,” does not indicate what method or reference standard you intend to use to establish the identity of the component. Also, the document you purport to be a specification sheet for Ascorbic Acid identifies “USP 39” as a method. We are unable to evaluate the adequacy of this response because it is unclear if “USP 39” is a method that can be used to determine identity of Ascorbic Acid.
3. 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, you did not establish any product specifications for the identity, purity, strength, and composition of your dietary supplement products.
We have reviewed your January 18, 2022 response to the form FDA 483 and we note the following. The documents you provided do not demonstrate that you have established specifications that provide standards to confirm the identity, purity, strength, and composition of the finished batch of your dietary supplements. For example, visual and organoleptic attributes are indicated to confirm the identity of your finished dietary supplement products, however those attributes are unacceptable to identify powdered products without a complementary identity test that is more specific to the analyte, such as HPLC with an indicated method or reference standard to establish identity. Other attributes indicated are limited to a calculated percentage of protein, fat and moisture content by NIR Spectroscopy, and pH by potentiometric measure. However, none of these attributes provide specific analytical standards to confirm the identity, purity, or strength of your finished products as these characteristics are shared by many of the finished products and would not be sufficient to distinguish them from each other.
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 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).
In addition, once you establish finished product specifications, you must verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c).
4. Your quality control personnel failed to approve or reject processes, specifications, written procedures, controls, tests, examinations and deviations or modifications that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically, your quality control personnel failed to complete quality control (QC) review entries in the calibration logs.
5. Your quality control personnel failed to review and approve all batch production records (BPR), as required by 21 CFR 111.123(a)(2). Specifically, your quality control personnel failed to review and approve all relevant sections of the batch records for your finished products MFX Pre Blue Ice Pop, Lot number 280110272113 and Creatine Candy LL, lot number CCLL09272100.
We are unable to evaluate the adequacy of your corrective action submitted in your January 18, 2022 response for this observation. We note that you provided a copy of a (b)(4) calibration log however, the log has no effective date, and no Quality Assurance approval dates or signatures.
6. You failed to include to include in your BPR complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). A BPR must include required information described in 21 CFR 111.260. Your BPRs for MFX Pre Blue Ice Pop, Lot number 280110272113, Creatine Candy LL, lot number CCLL09272100, and Isolate Whey Protein, Mocha Flavor, lot number 565312302151, failed to include required information under 21 CFR sections 111.260(b) through (n).
We are unable to evaluate the adequacy of your corrective action submitted in your January 18, 2022 response for this observation because you did not provide documentation of BPRs for review. We note that you provided 3 blank Master Manufacturing Records (MMRs) and we have the following comment. Batch records are required to accurately follow the appropriate MMR under 21 CFR section 111.255(c). The MMRs you provided are not specific to a product or batch size, as required by 21 CFR 111.205(a). Additionally, the templates do not include all required information of an MMR as required by 21 CFR 111.210 and therefore will not generate batch records that have all the required information under 21 CFR sections 111.260(b) through (n).
7. You failed to hold reserve samples using the same container-closure system in which the packaged and labeled dietary supplement is distributed, as required by 21 CFR 111.83(b)(1). Specifically, during the inspection you stated you collect (b)(4) from each manufactured batch, and it is held in a container-closure system different from that used for the finished packaged and labeled products.
We are unable to evaluate the adequacy of your corrective action submitted in your January 18, 2022 response for this observation. You stated that you cannot retain reserve samples using the same container-closure system in which the packaged and labeled dietary supplement is distributed due to facility space concerns. We note that if you are distributing a packaged and labeled dietary supplement, 21 CFR 111.83(b)(1) requires you to keep the reserve samples in a container-closure system that is the same as the container-closure system in which the dietary supplement is distributed.
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.
We also have the following comment:
1. Your firm includes expiration dates on the labels for the dietary supplement products you manufacture, including your Mocha Flavored Whey Protein Isolate, Lot # 565312302151, with an expiration date of December 30, 2023, and whey protein isolate component, Lot # (b)(4), with an expiration date of July 30, 2023. During the inspection, you informed our investigators that you did not conduct or have any data supporting the expiration dates listed on the product labels. Any expiration date you place on a product label should be supported by data [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
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.
Please send your reply to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer, Stephen.email@example.com and firstname.lastname@example.org. Or you may send hard copy correspondence to Mr. Rabe at: U.S. Food and Drug Administration 550 Main Street, Suite 4-930, Cincinnati, OH 45202.
If you have any questions regarding this letter, please contact Mr. Rabe via email or by telephone at: 513-322-0660.
Steven B. Barber
Program Division Director
Office of Human and Animal Foods – East 5