FairyGene, Inc.

WARNING LETTER FairyGene, Inc. MARCS-CMS 726976 — July 31, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-109 Product: Drugs Recipient: Recipient Name Mr. Yong Liu Recipient Title Chief Executive Officer FairyGene, Inc. 2 Pearl Buck Court, Suite 1 Bristol , PA 19007 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-109 July 31, 2026 Dear Mr. Liu: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, FairyGene, Inc., FEI 3023594691, at 2 Pearl Buck Court, Suite 1, Bristol, from January 12 to 15, 2026. 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). FDA Inspection and Review In addition, violations were identified and documented during a review of product labeling collected during the onsite inspection. Based on our review, “FROYA, Instant Rosacea, Acne & Redness Stopper,” “[Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM,” “[Norse], BODY ACNE KILLER, BODY BALM,” “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face,” and “PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a). We reviewed your January 28, 2026, response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP. During our inspection, our investigators observed specific violations including, but not limited to, the following. CGMP Violations 1. Your firm failed to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination; and failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(b) and 21 CFR 211.42(c)). Your firm contract manufactures over-the-counter (OTC) drug products as well as non-drug products. Your firm lacked adequate space and defined areas for equipment and materials to prevent mix-ups and contamination in the manufacturing of drug products. For example, our investigators observed inadequate material storage throughout your facility, with components and raw materials stored haphazardly on floors, along walls, and in hallways between packaging lines used for the manufacturing of drug products. In addition, materials lacked clear identification of contents, designated status (e.g., quarantined, approved, or rejected), intended use, or production run association. Your facility also lacked designated areas for quarantining incoming materials and segregating approved from rejected materials. Your lack of designated areas further compromises inventory control and increases the risk of mix-ups and contamination. Also, you conduct your drug manufacturing operations in a warehouse environment unsuitable for drug product manufacturing. For example, your drug manufacturing environment consisted of concrete floors, metal sheeting over cinderblock walls, exposed ceiling vents, exposed piping, exposed joists, and ceiling fans. Additionally, your lack of adequate ventilation systems for drug manufacturing areas can create risks for microbial and particulate contamination of drug products. While you state that you plan to acquire a new warehouse by Autumn 2026 for additional room expansion, your current environment is not of suitable construction or design to facilitate adequate cleaning and maintenance for drug manufacturing operations. In response to this letter, provide: A comprehensive, independent evaluation of your manufacturing, storage, packaging, labeling operations, and facility’s suitability for drug manufacturing. Provide an analysis including but not limited to the following factors: o Retrospective review of batches (i.e., defect types and frequencies; deviations; complaints; related investigations) o Facility layout and personnel/material flow o Equipment design, maintenance and repair history, and suitability for intended use o Assessment of whether current infrastructure (e.g., floors, walls, ceilings) can be adequately remediated or whether expansion, renovation, or relocation is necessary o Adequacy of ventilation and air handling systems for all manufacturing and packaging areas, including appropriate controls for airborne particulate and microbial contamination o Capability of facility surfaces to be adequately cleaned and sanitized in support of drug manufacturing operations A comprehensive, independent evaluation of your material control and segregation practices. Provide an analysis including but not limited to the following factors: o Appropriately designated areas for quarantined, approved, and rejected components and in-process materials o Procedures for material identification, segregation, and status control throughout the facility with applicable training 2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements; and failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 21 CFR 211.67(b)). Your firm failed to ensure that appropriate procedures are established and followed for cleaning and maintenance of your equipment used to manufacture drug products. Specifically, your firm’s cleaning and maintenance procedure lacked critical details, including types of cleaning agents, cleaning agent concentrations or dilutions, contact times, sampling requirements, and testing specifications. This deficiency is particularly concerning because your firm manufactures OTC drug products on the same non-dedicated equipment used to manufacture non-drug products. Additionally, per your cleaning procedure, equipment cleaning should be documented in a designated logbook and verified by a supervisor. However, your firm could not provide any cleaning or sanitization logs to demonstrate that cleaning was performed on your equipment. Additionally, while your batch records contained a designated step for documenting equipment cleaning, this step was not completed for multiple drug product lots. You lacked appropriate evidence that cleaning was performed or verified, including when cleaning was performed, who performed the cleaning, and what product was cleaned from the equipment. Furthermore, your cleaning practices were inadequate. For example, the (b)(4) you used in equipment cleaning repeatedly yielded too-numerous-to-count bioburden results during routine sampling. Despite these recurring out-of-limit bioburden results, your firm failed to take appropriate corrective actions and continued using this (b)(4) for equipment cleaning without remediation. Inadequate cleaning procedures and the use of microbiologically contaminated (b)(4) for equipment cleaning create a significant risk of microbial contamination and cross-contamination of drug products subsequently manufactured on that equipment. In response to this letter, provide: Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case: o Drugs with higher toxicities o Drugs with higher drug potencies o Drugs of lower solubility in their cleaning solvents o Drugs with characteristics that make them difficult to clean o Swabbing locations for areas that are most difficult to clean o Maximum hold times before cleaning In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product. A summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment. A corrective action and preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations. A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system. Include a comprehensive evaluation of vulnerabilities of (b)(4) system design and control, and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system (b)(4) , materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.) A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm. Include the current action/alert limits for total counts and objectionable organisms used for your (b)(4) system. A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4) , USP monograph specifications and appropriate microbial limits. 3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure: Adequate procedures ensuring appropriate production and process controls for drug product manufacturing and qualification of equipment used to manufacture drug products (21 CFR 211.100(a)). Establishment of an adequate, ongoing stability program (21 CFR 211.166(a)). Establishment of adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)). Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download, as well as ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download. In response to this letter, provide: A 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 o Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control. 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. A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies. 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 All procedures that describe these and other elements of your remediated stability program. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with these products or operations. Unapproved New Drug Violations Based on a review of product labels/labeling, “FROYA, Instant Rosacea, Acne & Redness Stopper,” “[Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM,” “[Norse], BODY ACNE KILLER, BODY BALM,” “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face,” and “PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as a drug include, but may not be limited to, the following: FROYA, Instant Rosacea, Acne & Redness Stopper “… Instant Rosacea, Acne … Stopper” [from product carton] [Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM “ACNE SCARS HEALER & PREVENTER … FACE BALM [from product carton] [Norse], BODY ACNE KILLER, BODY BALM “BODY ACNE KILLER.…” [from product carton] FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face “… Hyper Fast Eczema & Psoriasis Stopper for Body & Face” [from product labeling] PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM “… ULTIMATE JOINT & MUSCLE REPAIR BALM” [from product carton] Based on the above labeling evidence, “FROYA, Instant Rosacea, Acne & Redness Stopper,” “[Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM,” “[Norse], BODY ACNE KILLER, BODY BALM,” “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face,” and “PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM” are intended for various nonprescription drug uses. 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 these drug products identified above. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. However, “FROYA, Instant Rosacea, Acne & Redness Stopper,” “[Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM,” “[Norse], BODY ACNE KILLER, BODY BALM,” “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face,” and “PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM” do not conform to the conditions specified in their respective monographs for the reasons described below. Acne Drug Products Based on the above labeling claims, “FROYA, Instant Rosacea, Acne & Redness Stopper,” “[Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM” and “[Norse], BODY ACNE KILLER, BODY BALM” are intended for use as over-the-counter (OTC) acne drug products and must conform to OTC Monograph M006: Topical Acne Drug Products for OTC Human Use (M006) in order to be GRASE and not new drugs. 1 However, as formulated and labeled these acne drug products do not comply with the conditions specified under M006. Specifically, none of these products labeled ingredients are acceptable active ingredients for OTC topical acne drug products under M006. Skin Protectant Product and Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Product Based on the above labeling claims, “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face” is intended for use as an OTC skin protectant and for the control of psoriasis and must conform to OTC Monograph M016: Skin Protectant Drug Products for Over-the-Counter Human Use and OTC Monograph M032: Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for OTC Use in order to be GRASE and not a new drugs. 2 However, as formulated and labeled this drug product does not comply with the conditions specified under M016 and M032. Specifically, none of “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face” labeled ingredients are acceptable active ingredients for OTC psoriasis drug products and/or OTC skin protectant drug products for eczema relief. External Analgesic Drug Products Based on the above labeling claims, “PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM” is intended for use as an OTC external analgesic drug product and must confirm to the OTC Monograph M017: External Analgesic Drug Products for OTC Human Use in order to be GRASE and not a new drug. 3 However, as formulated and labeled this drug product does not comply with the conditions specified under M017. Specifically, the product labeling includes intended uses that are not permitted for OTC external analgesic products in M017. Claims such as “joint & muscle repair” go beyond the general intended uses for an OTC external analgesic drug product and do not conform to the permitted uses set forth in M017. Thus, “FROYA, Instant Rosacea, Acne & Redness Stopper,” “[Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM,” “[Norse], BODY ACNE KILLER, BODY BALM,” “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face,” and “PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM” products do not comply with the applicable conditions specified in their corresponding monographs, nor have they otherwise been found to be GRASE. 4 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 applications in effect for these products, these products are unapproved new drugs. The introduction or delivery for introduction of these unapproved new drug 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 “FROYA, Instant Rosacea, Acne & Redness Stopper,” “[Norse], ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM,” “[Norse], BODY ACNE KILLER, BODY BALM,” “FROYA, Hyper Fast Eczema & Psoriasis Stopper for Body & Face,” and “PRIMAL VIKING, ULTIMATE JOINT & MUSCLE REPAIR BALM” 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 subject of an application 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 commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). 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. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA. 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. 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. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3023594691 and ATTN: Bryce Hammer. Sincerely, /S/ Francis Godwin Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research /S/ Dacia Quick, M.S. Branch Chief Office of Unapproved and Labeling Compliance Signed on behalf of: /S/ Tina Smith Captain, U.S. Public Health Service Director Office of Unapproved Drugs & Labeling Compliance Office of Compliance Center for Drug Evaluation and Research _____________________ 1 M006 reflects the conditions set forth in the relevant final orders established and in effect under section 505G; see Order ID OTC000013, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/. 2 M016 and M032 reflects the conditions set forth in the relevant final orders established and in effect under section 505G; see Order ID OTC000005 and Order ID OTC000021, respectively, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/. 3 M017 reflects the conditions set forth in the relevant final orders established and in effect under section 505G; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/. 4 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Instant Rosacea, Acne & Redness Stopper,” “ACNE SCARS HEALER & PREVENTER 2.0, FACE BALM,” “BODY ACNE KILLER, BODY BALM,” “Hyper Fast Eczema & Psoriasis Stopper for Body & Face,” and “ULTIMATE JOINT & MUSCLE REPAIR BALM” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b). Content current as of: 08/11/2026 Regulated Product(s) Drugs