Has Foshan Miwei Cosmetics Co., Ltd. had FDA enforcement actions before?

This is the only FDA Warning Letter Argus HQ has on file for Foshan Miwei Cosmetics Co., Ltd. as of 2026-04-28. Argus ingests new FDA enforcement records daily.

When did FDA issue the warning letter to Foshan Miwei Cosmetics Co., Ltd.?

FDA issued the letter (MARCS-CMS 722272) on 2026-04-20 and posted it publicly on fda.gov on 2026-04-28.

criticalCenter for Drug Evaluation and Research (CDER)· Warning Letter

Nonprescription/OTC: FDA Warning Letter to Foshan Miwei Cosmetics Co., Ltd., 2026-04-20

Name: FDA Warning Letter Record — Foshan Miwei Cosmetics Co., Ltd.
Creator: Argus HQ
License: https://argushq.ai/methodology

Letter issued 2026-04-20 · posted to fda.gov 2026-04-28.

Subject as published: Nonprescription/OTC

TL;DR

Here's the summary: FDA issued a Warning Letter to Foshan Miwei Cosmetics Co., Ltd. on 2026-04-20 citing: Nonprescription/OTC. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/foshan-miwei-cosmetics-co-ltd-722272-04202026

Argus analysis

Foshan Miwei Cosmetics Co., Ltd. (MARCS-CMS 722272, FEI 3017118698) received an FDA Warning Letter dated April 20, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: Nonprescription/OTC. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on April 28, 2026.

Nonprescription/OTC letters typically cite the relevant OTC monograph under 21 CFR Part 330 (or the newer OTC monograph order process under the CARES Act) alongside 21 USC 352 misbranding provisions. Common findings involve active ingredients, dosing, or labeling claims that fall outside the applicable monograph's permitted conditions.

FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.

Severity context

Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.

Regulatory background

FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.

What peer compliance teams typically do next

Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.

Excerpt from the FDA Warning Letter (public domain, 17 USC §105)

WARNING LETTER Foshan Miwei Cosmetics Co., Ltd. MARCS-CMS 722272 — April 20, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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, ap…

Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.

The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.

Read the full letter on fda.gov ↗

Frequently asked questions

Has Foshan Miwei Cosmetics Co., Ltd. had FDA enforcement actions before?: This is the only FDA Warning Letter Argus HQ has on file for Foshan Miwei Cosmetics Co., Ltd. as of 2026-04-28. Argus ingests new FDA enforcement records daily.
What FDA violations was Foshan Miwei Cosmetics Co., Ltd. cited for?: The FDA Warning Letter to Foshan Miwei Cosmetics Co., Ltd. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: Nonprescription/OTC. Classification: Warning Letter.
When did FDA issue the warning letter to Foshan Miwei Cosmetics Co., Ltd.?: FDA issued the letter (MARCS-CMS 722272) on 2026-04-20 and posted it publicly on fda.gov on 2026-04-28.
Is the FDA warning letter to Foshan Miwei Cosmetics Co., Ltd. publicly available?: Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/foshan-miwei-cosmetics-co-ltd-722272-04202026.

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methodology

The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.

Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Nonprescription/OTC: FDA Warning Letter to Foshan Miwei Cosmetics Co., Ltd., 2026-04-20. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-foshan-miwei-cosmetics-co-ltd-2026-04-20-warning-letter

MLA

"Nonprescription/OTC: FDA Warning Letter to Foshan Miwei Cosmetics Co., Ltd., 2026-04-20." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-foshan-miwei-cosmetics-co-ltd-2026-04-20-warning-letter.

Chicago

Argus HQ Research. "Nonprescription/OTC: FDA Warning Letter to Foshan Miwei Cosmetics Co., Ltd., 2026-04-20." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-foshan-miwei-cosmetics-co-ltd-2026-04-20-warning-letter.

BibTeX

@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_foshan_miwei_cosmetics_co_ltd_2026_04_20_warning_letter_2026,
  title = {Nonprescription/OTC: FDA Warning Letter to Foshan Miwei Cosmetics Co., Ltd., 2026-04-20},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/fda/warning-letter/fda-wl-foshan-miwei-cosmetics-co-ltd-2026-04-20-warning-letter},
  note = {Accessed: July 13, 2026}
}