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  1. Warning Letters

WARNING LETTER

Foshan Miwei Cosmetics Co., Ltd. MARCS-CMS 722272 —

Delivery Method:
Via Electronic Mail - Return Receipt Requested
Reference #:
320-26-70
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. Zhong Muqi
Recipient Title
Chief Executive Officer
Foshan Miwei Cosmetics Co., Ltd.

801 & 802, Building 9, Baofa Jewellry Industry Centre
No. 1 Feicui Road, Yang’e Village Committee, Lunjiao Town
Shunde Qu
Foshan Shi
Guangdong Sheng,
China

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Warning Letter 320-26-70

April 20, 2026

Dear Mr. Muqi:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Miwei Cosmetics Co., Ltd., FEI 3017118698, located at 801 & 802, Building 9, Baofa Jewellery Industry Centre, No. 1, Feicui Road, Yang’e Village Committee, Lunjiao Town, Shunde District, Foshan City, Guangdong Province, from October 20 to 24, 2025.

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, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Furthermore, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are misbranded under 502(a), 502(f)(1), and 502(ee) of the FD&C Act, 21 U.S.C. 352(a), (f)(1), and (ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

We reviewed your November 7, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

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

CGMP Violations

1. 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. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

Your firm manufactures over-the-counter (OTC) (b)(4) drug products. You did not test your drug products for the strength of each active ingredient prior to release and distribution. You also failed to conduct adequate microbiological testing for each batch of your OTC (b)(4) drug products. For example, your certificates of analysis (COAs) for (b)(4) batch (b)(4) and (b)(4) batch (b)(4) lacked active ingredient assay values and results for specified microorganisms.

Full release testing, including for identity, strength, impurities, and microbiological limits, must be performed prior to drug product release and distribution.

In response to this letter, provide:

  • A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.
  • An action plan and timelines for conducting full chemical and microbiological testing of retain 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.
  • A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
  • A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.

2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(1) and 211.84(d)(2)) and (21 CFR 211.84(d)(6)).

Active Ingredients and Components at Risk for (b)(4) Contamination

You failed to perform adequate identity testing of each component lot used in the manufacture of your drug products including your active pharmaceutical ingredients, such as (b)(4). Additionally, your firm failed to perform adequate identity testing of each shipment of each lot of incoming components at high risk of (b)(4) contamination. For example, your firm’s in-house raw material report for (b)(4) lot (b)(4), used to manufacture (b)(4) batch number (b)(4), lacked data for identity, (b)(4) limits. Furthermore, you relied on your suppliers’ COAs without establishing the reliability of each of your component supplier’s test analysis at appropriate intervals.

Identity testing for (b)(4) and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of (b)(4). Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of this component for use in the manufacture of your drug products.

The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4)

(b)(4) Used as a Component in Drug Products

Your firm failed to adequately monitor (b)(4) and the microbiological quality of (b)(4) used as a component in drug product manufacturing. (b)(4) must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.

In your response, you state that you will establish raw material specifications, testing of all incoming materials, a supplier qualification procedure, and a microbial control program for your (b)(4) system.

Your response is inadequate because it lacks sufficient details on the remediation of your incoming materials testing program. It also does not include a retrospective review, analysis, and risk assessment for distributed drug products within expiry.

In response to this letter, provide:

  • A commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4).
  • A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4), 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 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 (b)(4), and certain additional high-risk components we note that this includes the performance of (b)(4).
  • A comprehensive, independent review of your material system, including but not limited to:
    o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified
    o an assessment of all materials to determine whether they are consistently of acceptable quality
    o a review to ensure assigned expiration or retest dates are appropriate (supported by data)
    o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions
  • Based on a thorough review, provide a summary of your systems CAPA to remediate the vendor qualification program and 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 SOP 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 procedure governing your program for ongoing control and monitoring that ensures your (b)(4) system consistently produces (b)(4) that meets (b)(4), USP monograph specifications and appropriate microbial limits.

3. Your firm 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)).

Your firm failed to establish an adequate stability program with data demonstrating that the drug products remain acceptable throughout the labeled expiry date. For example, you assigned (b)(4) expiration dates to (b)(4) batch (b)(4), (b)(4) batch (b)(4), and (b)(4) batch (b)(4) without initiating stability testing.

Without appropriate stability studies, you lack sufficient scientific evidence to support that your drug products retain their quality attributes throughout the labeled expiry period or determine appropriate storage conditions for your drug products.

In your response, you state that you will begin stability studies. Your response is inadequate because it lacks sufficient detail describing your stability program procedures and protocols, or equipment for these studies.

In response to this letter, provide:

  • A comprehensive 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.

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

You lacked an adequate quality unit (QU) to provide oversight for the manufacture of your drug products. For example, you did not review, approve, or implement procedures for critical quality operations such as handling non-conformances, change control, training management, and handling out-of-specification events.

In your response, you commit to establishing and implementing quality oversight procedures.

Your response is inadequate. Although you commit to addressing the observations, your response lacks sufficient details about the systemic remediations needed for your QU and your quality system.

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

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 audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions 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.

Unapproved New Drugs and Misbranded Drug Violations

Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer 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.

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

Trust MD SPF 30 Stem Cell Face Cream

“SPF 30…Drug Facts…Uses…Helps prevent sunburn…PLANT-BASED STEM CELLS: Improves texture, fine lines, and skin tone by restoring cells natural balance pH. Promotes collagen production…SODIUM HYALURONATE:…It repairs and protects youthful skin cells...Vitamins B5, C, …B5 binds moisture to skin cells, which plumps and firms the skin, and erases fine lines…C…promotes collagen production…” [from product label]

inBlair Elevate SPF 15 Moisturizer

“SPF 15…Drug Facts… Use… Helps prevent sunburn…To aide in the protection against harmful UV rays…VITAMIN B3 can reduce hyperpigmentation, & inflammation” [from product label]

Unapproved New Drug Violations

Based on the above labeling evidence, your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are drug products intended for use as over-the-counter (OTC) sunscreen drug products. As described below, these OTC 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).

In general, 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), unless it is lawfully marketed under section 505G of the FD&C Act, 21 U.S.C 355h. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for any of 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 "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to nonprescription (OTC) sunscreen drug products, in order to be GRASE and not new drugs, the product must, among other things, conform to the conditions of use set forth in the applicable OTC monograph(s). Nonprescription (OTC) sunscreen drug products are addressed in the “Sunscreen Drug Products for Over-the-Counter Human Use” (M020)2.

However, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products described above do not comply with conditions specified in M020 for the reasons below.

As labeled, "Trust MD SPF 30 Stem Cell Face Cream" includes the active ingredients Plant-Based Stem Cells, Sodium Hyaluronate, and Vitamins B and C that are not permitted active ingredients under M020.10. CFR 201.66(b)(2) defines “active ingredient” to mean “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” Although the product label does not specifically list Plant-Based Stem Cells, Sodium Hyaluronate, and Vitamins B and C as active ingredients in the Drug Facts, the product labeling makes claims such as “PLANT-BASED STEM CELLS: Improves texture, fine lines, and skin tone by restoring cells natural balance pH. Promotes collagen production…SODIUM HYALURONATE:…It repairs and protects youthful skin cells...Vitamins B5, C, …B5 binds moisture to skin cells, which plumps and firms the skin, and erases fine lines…C…promotes collagen production…” which demonstrate that these are “active ingredients” in your sunscreen products because they are intended to furnish pharmacological activity.

In addition, as labeled, "inBlair Elevate SPF 15 Moisturizer" includes the active ingredient VITAMIN B3 that is not a permitted active ingredient under M020.10. Although the product label does not specifically list VITAMIN B3 as an active ingredient in the Drug Facts panel for “inBlair Elevate SPF 15 Moisturizer,” label claims such as “VITAMIN B3 can reduce hyperpigmentation, & inflammation” demonstrate that this is an “active ingredient” in your sunscreen product because it is intended to furnish pharmacological activity.

Thus, your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products identified above do not comply with the conditions set forth in M020 and have not otherwise been found GRASE.3 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 in which these products would be legally marketed without an approved application. Because there are no applications in effect for these products, the Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products are unapproved new drugs.

The introduction or delivery for introduction of 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

Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the labeling for these products are false or misleading for several reasons. First, the labeling for Trust MD SPF 30 Stem Cell Face Cream identifies Plant-Based Stem Cells, Sodium Hyaluronate, Vitamins B, and C as inactive ingredients but represents these ingredients as having purported active pharmacological properties. Similarly, labeling for inBlair Elevate SPF 15 Moisturizer identifies Vitamin B3 as an inactive ingredient but represents this ingredient as having purported active pharmacological properties. Even if Plant-Based Stem Cells, Sodium Hyaluronate, Vitamins B, C, and B3 could be considered inactive ingredients in these products, the prominent featuring of these substances on the product labeling causes these products to be misbranded under section 502(a) of the FD&C Act, which deems a drug to be misbranded if its labeling is “false or misleading in any particular,” and under 21 CFR 201.10(c)(4).4 Under 21 CFR 201.10(c)(4), “[t]he labeling of a drug may be misleading by reason . . . [of] the featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.”

Furthermore, your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products are further misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), because their labeling does not bear adequate directions for use. Here, the directions set forth in M020.50(e) are required for a sunscreen drug product to be legally marketed under section 505G of the FD&C Act. This monograph labeling also falls within the scope of the directions described in section 502(f)(1) of the FD&C Act. Your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer fails to include “[bullet] apply [select one of the following: `Liberally' or `generously'] [and, as an option: `And evenly'] 15 minutes before sun exposure" and “[bullet] children under 6 months of age: Ask a doctor" as required under M020.50(e)(1)(ii) and (iv) and fails to include "[bullet] reapply at least every 2 hours [bullet] use a water resistant sunscreen if swimming or sweating" as required under M020.50(e)(4). The omission of these monograph directions from your products’ labeling renders them misbranded under section 502(f)(1).

In addition, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are also misbranded under section 502(ee) because as nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, these products 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).

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.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on February 13, 2026.

Correct any violations promptly. 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 any violations.

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Foshan Miwei Cosmetics Co., Ltd., 801 & 802, Building 9, Baofa Jewellery Industry Centre, No. 1, Feicui Road, Yang’e Village Committee, Lunjiao Town, Shunde District, Foshan City, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated or misbranded may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) and are misbranded under section 502 of the FD&C Act, respectively.

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 3017118698 and ATTN: Marisa Heayn.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

/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 i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document.

2 M020, in the final administrative order, Over-the-Counter Monograph M020: Sunscreen Drug Products for OTC Human Use, reflects the conditions in the relevant final order established and in effect under section 505G. See Order ID OTC000034, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.

3 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that "Trust MD SPF 30 Stem Cell Face Cream" and "inBlair Elevate SPF 15 Moisturizer" products 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).

4 Additionally, Trust MD SPF 30 Stem Cell Face Cream also prominently features vitamin E on the labeling and inBlair Elevate SPF 15 Moisturizer also prominently features collagen peptides on the labeling that creates an impression of value greater than its functional role in the formulation that further causes these products to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

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