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WARNING LETTER

Little Moon Essentials, LLC MARCS-CMS 677260 —

Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Mr. William Richard Wilson
Recipient Title
Director of Operations
Little Moon Essentials, LLC

501 Old Griffin Road
Dania Beach, FL 33004
United States

billy@littlemoonessentials.com
Issuing Office:
Division of Pharmaceutical Quality Operations II

United States

DATE: 9/17/2024

Case #: 677260

WARNING LETTER

Dear Mr. Wilson:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Little Moon Essentials, LLC, FEI 3017366969, at 501 Old Griffin Road, Dania Beach, from January 16 to 18, 2024.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

In addition, your “Little Moon ESSENTIALS Topical Analgesic ASANA KISSER,” “Little Moon ESSENTIALS Topical Analgesic ASS KISSER,” “Little Moon ESSENTIALS VITAL VAPOR BALM Topical Analgesic,” “Little Moon ESSENTIALS Dream Cream,” and “Little Moon ESSENTIALS Magical Muscle Oil” drug products, hereafter referred to collectively as “Little Moon Topical Analgesic drug products,” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a), 331(d). In addition, these products are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

We also noted that some of the products you manufacture may be regulated as cosmetics, as defined in section 201(f) of the FD&C Act. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. Under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

Further, your facility may be subject to requirements of the Modernization of Cosmetic Regulations Act of 2022 (MoCRA) Information on MoCRA requirements may be found at www.fda.gov.

We reviewed your February 7, 2024, response to our Form FDA 483 in detail.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm failed to test all incoming raw materials used to manufacture your over-the-counter (OTC) drug products, including active pharmaceutical ingredients (API), and other high-risk components. You relied on your supplier’s certificate of analysis (COA) in lieu of testing each component for purity, strength, identity, and quality. You also did not establish a supplier qualification program to assess (i.e., initially, and periodically) the reliability of your supplier’s test results for these attributes.

In addition, your firm has not demonstrated that the water you used as a component for manufacturing drug products is suitable for aqueous-based dosage forms and, at a minimum, meets the (b)(4) Water United States Pharmacopeia (USP) monograph.

In your response, you commit to implement a supplier qualification program. In addition, you state you will engage a third-party laboratory to qualify your suppliers by performing testing on the (b)(4) raw material orders you receive. We acknowledge your decision to discontinue the manufacture of your Clear Breeze Plus hand sanitizer product.

Your response is inadequate. You fail to provide sufficient details describing how you will ensure your components are of appropriate quality before use. You also fail to consider a retrospective assessment of all raw materials and components used in your distributed drug products to ensure they meet all required specifications.

Products Contain Ethanol

You manufacture drugs that contain ethanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol at https://www.fda.gov/media/173005/download.

Products Contain Glycerin

We also note that glycerin is a component used in your drug products. As a drug manufacturer, you are responsible for performing specific identity tests for all incoming shipments of component lots prior to release for use in manufacturing.

The use of ingredients contaminated with Diethylene Glycol (DEG) or Ethylene Glycol (EG) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

In response to this letter, provide:

  • A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
  • The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
  • A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedures (SOPs) that describes this COA validation program.
  • A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
  • A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing reserves for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a reserve of a component lot is unavailable, perform reserve sample testing of all implicated finished drug product batches for the presence of DEG and EG.
  • A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
  • A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.
  • Methanol testing for all hand sanitizer batches released and distributed in the United States within expiry.

2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Your firm failed to perform analytical and microbiological release testing for each batch of your OTC topical drug products prior to distribution, including Asana Kisser (topical analgesic).

Drug product batches must be tested for identity, strength, quality, and purity prior to release. Testing is an essential part of ensuring that the drug products you manufacture conform to all predetermined quality attributes and are appropriate for their intended use. Without adequate testing, you lack basic data to support that each drug product batch conforms to appropriate specifications before release.

In your response, you state you will create a new product log to ensure all final product specifications are documented before release. You also commit to create and train a “quality control department” to perform final inspection of products prior to release to the market and to ensure SOPs are followed. We acknowledge your subsequent decision to conduct product testing.

Your response is inadequate because your do not provide sufficient evidence to describe how you will ensure your finished products meet the appropriate quality standards prior to release. You also fail to provide a detailed risk assessment addressing the potential effects of releasing drug product to the market without established specifications to ensure their identity, strength, quality, and purity.

In response to this letter, provide:

  • A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a batch disposition decision.

    o An action plan and timelines for conducting full chemical and microbiological testing of reserve samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
    o A summary of all results obtained from testing reserve samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

3. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. (21 CFR 211.100(a)).

Your firm failed to demonstrate that you have validated the manufacturing processes for all your drug products and provide assurance you are capable of consistently delivering a quality product.

During the inspection, you stated you did not validate the (b)(4) manufacturing processes used in the production of your drug products. Notably, although you typically manufacture drug products per the (b)(4), you stated you can also incorporate (b)(4) instead of waiting for (b)(4) to complete the (b)(4) step.

In your response, you state you need to update your written production procedures and create formal SOPs. You commit to only using “(b)(4)” to manufacture your product bases. You also state you will engage a third-party for the testing of samples.

Your response is inadequate. You have not demonstrated that your manufacturing processes are designed, controlled, and reproducibly yield batches of uniform character and quality.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies includes intensive monitoring and testing of throughout each significant process stage to characterize intra-batch variation and evaluates batches to determine whether an initial state of control has been established.

Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.

See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.

In response to this letter, provide:

  • A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
  • A timeline for performing process performance qualification (PPQ) for each of your marketed drug products.
  • Include your process performance protocol(s), and written procedures for qualification of equipment and facilities.
  • Provide a detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
  • An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.
  • Timelines for completed process performance qualification for marketed drug products for which a state of control has not been established.

4. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing. Your firm also failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates. (21 CFR 211.166(a) and 211.137(a)).

Your firm failed to establish an adequate stability program, and lacked chemical and microbial testing data to demonstrate that your OTC drug products will remain acceptable throughout their assigned five-year expiry period.

During the inspection, you stated your drug product expiration dating was based on the shelf-life of the raw materials. Full shelf-life stability studies were not conducted for your finished drug products.

In your response, you commit to implement a product stability program and to send batch samples to a third-party laboratory for testing.

Your response is inadequate. You fail to provide data to demonstrate that the chemical and microbiological properties of your drug products will remain within specification throughout their expiry period. You also fail to provide interim measures to address whether your drug products that remain on the market have adequate stability data. For products without appropriate stability studies, there is insufficient scientific evidence to support that drug products will meet established specifications and retain their quality attributes through their labeled expiry.

In response to this letter, provide:

  • A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:

    o Stability indicating methods
    o Stability studies for each drug product in its marketed container-closure system before distribution is permitted
    o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid
    o Detailed definition of the specific attributes to be tested at each station (timepoint)
    o Improved procedures that describe the listed elements of your remediated stability program.

  • A comprehensive independent assessment of all drug products in the U.S. market to determine if you have data to support that they conform to specifications throughout their shelf-life, including evaluating storage conditions, differences in each formulation, packaging configurations, and all historical stability studies that have been performed. If there are gaps in the data needed to scientifically support that your drug products retain their quality attributes through their labeled shelf-life, provide a CAPA plan which will include an impact assessment for any batches that remain within their shelf-life in the market.
  • A summary of results from testing reserve samples within expiry for all drug product batches not currently in your existing stability program. Testing of each batch should be completed within 60 days of this letter. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients as well as microbiological quality of each batch. If testing yields an out-of-specification (OOS) result, indicate the corrective actions you will take, including notifying customers and initiating recalls.

5. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).

Your firm failed to establish adequate written procedures defining quality unit (QU) responsibilities and controls. For example, your firm failed to establish adequate procedures for out-of-specification (OOS) investigations, CAPA, equipment qualification and process validation, stability program, reserve sample program, recalls, and annual product reviews.

It is your responsibility as a drug manufacturer to comply with all CGMP requirements including, but not limited to, ensuring that the roles and responsibilities of QU are understood and fulfilled.

In your response, you indicate you will create a quality control department and include responsibilities for final inspection to ensure product conformity prior to release to the market and to ensure SOPs are followed. You also state you will create a complaint and investigation registry and include procedures to document investigations, CAPAs, and the stability program, among others.

Your response is inadequate. You do not provide a detailed CAPA plan and supporting documentation to systematically address the deficiencies. You also fail to provide a comprehensive assessment and remediation plan of your quality systems to ensure they function effectively.

In response to this letter, provide:

  • An independent comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:

    o A determination of whether procedures used by your firm are robust and appropriate
    o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
    o A complete and final review of each batch and its related information before the QU disposition decision
    o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

Quality Systems

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Unapproved New Drug and Misbranded Drug Violations

“Little Moon ESSENTIALS Topical Analgesic ASANA KISSER”, “Little Moon ESSENTIALS Topical Analgesic ASS KISSER”, “Little Moon ESSENTIALS VITAL VAPOR BALM Topical Analgesic”, “Little Moon ESSENTIALS Dream Cream” and “Little Moon ESSENTIALS Magical Muscle Oil” hereafter, referred to as “Little Moon Topical Analgesic products are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C) because they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as over-the-counter (OTC) external analgesic drug products.

Examples from the product labeling that provide evidence of the intended uses (as defined by 21 CFR 201.128) of these products include, but may not be limited to, the following:

“Little Moon ESSENTIALS Topical Analgesic ASANA KISSER”
    “Uses temporarily relieves minor pain associated with 􀃂 simple backache 􀃂 muscle strains 􀃂 sprains 􀃂 bruises” [from your product labels]

“Little Moon ESSENTIALS Topical Analgesic ASS KISSER”
   “Uses temporarily relieves minor pain associated with 􀃂 simple backache 􀃂 muscle strains 􀃂 sprains 􀃂 bruises” [from your product labels]

“Little Moon ESSENTIALS VITAL VAPOR BALM Topical Analgesic”
  “Uses for the temporary relief of minor aches and pains of muscles and joints associated with 􀃂 simple backache 􀃂 muscle strains 􀃂 sprains 􀃂 bruises” [from your product labels]

“Little Moon ESSENTIALS Dream Cream”
  “Uses - for the temporary relief of minor aches and pains of muscles and joints associated with 􀃂 simple backache 􀃂 muscle strains 􀃂 sprains 􀃂 bruises” [from your product labels]

“Little Moon ESSENTIALS Magical Muscle Oil”
  “Uses - for the temporary relief of minor aches and pains of muscles and joints associated with 􀃂 simple backache 􀃂 muscle strains 􀃂 sprains 􀃂 bruises” [from your product labels]

Unapproved New Drug Violations

Based on the above labeling claims, your Little Moon Topical Analgesic products are intended for use as external analgesic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p) if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above.

Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as your Little Moon Topical Analgesic drug products, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph(s), here, “Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use” (“M017”).1 However, your Little Moon Topical Analgesic drug products do not conform to the conditions specified in M017 for the reasons described below.

Your Little Moon Topical Analgesic drug products are labeled for use as counterirritant external analgesic drug products because they include claims to temporarily relieve muscular and joint aches and pains. The labels list the active ingredient, camphor, in the following strengths,1.35% camphor, for “Topical Analgesic ASANA KISSER” and “Topical Analgesic ASS KISSER,” 0.6% camphor, for “VITAL VAPOR BALM Topical Analgesic,” 0.45% camphor, for “Dream Cream,” and 1.95% camphor, for “Magical Muscle Oil” falls below the range of 3%-11% when used as a counterirritant as required by M017.12(b)(1).

Therefore, your Little Moon Topical Analgesic drug products do not comply with the applicable conditions set forth in M017 and have not otherwise been found GRASE.2 Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no approved applications in effect for these products, these products are unapproved new drugs. The introduction or delivery for introduction of these products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

Misbranded Drug Violations

In addition, your Little Moon Topical Analgesics drug products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section, and are not the subjects of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Drug Recall and Production Suspended

On June 20, 2024, you initiated the voluntary recall of certain drugs due to the significant CGMP violations.

We acknowledge your commitment to suspend production of drugs for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.

If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Your written notification should refer to case # 677260.

Please electronically submit your reply, on company letterhead, to Mark W. Rivero, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov, and copy DCB, Ronda Loyd-Jones, at Ronda.Loyd-Jones@fda.hhs.gov.

If you have questions regarding the contents of this letter, you may contact Mr. Rivero via phone at (954) 759-7718 or email at mark.rivero@fda.hhs.gov.

Sincerely,
/S/

Ronda Loyd-Jones
Acting Program Division Director
Office of Pharmaceutical Quality Operations,
Division II

_________________________

1 M017 reflects the conditions as set forth in the relevant final order established and in effect under section 505G. (See Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.)

2 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Little Moon ESSENTIALS Topical Analgesic ASANA KISSER”, “Little Moon ESSENTIALS Topical Analgesic ASS KISSER,” “Little Moon ESSENTIALS VITAL VAPOR BALM Topical Analgesic,” “Little Moon ESSENTIALS Dream Cream,” “Little Moon ESSENTIALS Magic Muscle Oil” are GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

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