Warning Letter 320-26-58
[中譯] 警告信 320-26-58

April 2, 2026
[中譯] 2026年4月2日

Dear Ms. Mattina:
[中譯] Mattina 女士您好：

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Purolea Cosmetics Lab, FEI 3011669383, at 12782 Currie Ct., Livonia, from October 28 to 30, 2025.
[中譯] 美國食品藥物管理局 (FDA) 於 2025 年 10 月 28 日至 30 日，查核了您位於 12782 Currie Ct., Livonia 的藥品製造廠 Purolea Cosmetics Lab (FEI: 3011669383)。

Your drug products are adulterated under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(A), in that they have been prepared, packed, or held under insanitary conditions.
[中譯] 依據聯邦食品、藥品和化妝品法案 (FD&C Act) 第 501(a)(2)(A) 條 (21 U.S.C. 351(a)(2)(A))，您的藥品被判定為摻偽，因為它們是在不衛生的條件下配製、包裝或保存的。

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).
[中譯] 本警告信總結了製劑現行優良製造規範 (CGMP) 的重大違規事項。請參閱聯邦法規彙編 (CFR) 第 21 篇第 210 及 211 部分。

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 FD&C Act, 21 U.S.C. 351(a)(2)(B).
[中譯] 由於貴廠的製造、加工、包裝或保存的方法、設施或管制不符合 CGMP，依據 FD&C Act 第 501(a)(2)(B) 條，您的藥品被視為摻偽。

In addition, the FDA reviewed the product labels for drug products manufactured at your facility, including "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief." Based on our review, these products 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). As explained further below, introducing or delivering "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). These drug products are especially concerning from a public health perspective as they are intended to treat serious and/or life-threatening conditions such as shingles and genital herpes.
[中譯] 此外，FDA 審查了貴廠生產之藥品的產品標籤，包含「Dermveda Extra Strength Shingles Relief」與「Dermveda Extra Strength Ultra Genital Herpes Relief」。基於我們的審查，這些產品屬於未經核准之新藥，違反了聯邦法規。這些旨在治療帶狀皰疹及生殖器皰疹等嚴重疾病的藥品，從公共衛生角度來看特別令人擔憂。

We acknowledge receipt of your response to our Form FDA 483. 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.
[中譯] 我們確認收到您對 FDA 483 表格的回覆。您的回覆並不充分，因為您未能提供評估所需的支持性文件，或提供已採取矯正措施以使營運符合 CGMP 的充分證據。

During our inspection, our investigator observed specific violations including, but not limited to, the following.
[中譯] 查廠期間，我們的查帳員觀察到具體違規事項，包含但不限於以下內容：

Insanitary Conditions
[中譯] 不衛生的環境條件

Your drug products are adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, or held under insanitary conditions. During the inspection, our investigator observed the presence of insects, filth, leaves, and clutter in several areas within your facility.
[中譯] 由於在查核期間觀察到廠區內多處有昆蟲、污垢、樹葉與雜物，您的藥品被判定為摻偽。

Furthermore, your facility lacked adequate separation to prevent contamination from other internal or external contaminants. For example, the facility docking bay door, when opened, would directly expose manufacturing to the outside environment.
[中譯] 此外，貴廠缺乏適當的區隔以防止內部或外部污染。例如，碼頭裝卸門開啟時，會將製造區域直接暴露於外部環境中。

CGMP Violations
[中譯] CGMP 違規事項

1. Your firm 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(b)
[中譯] 1. 貴公司未能針對每批藥品執行適當的實驗室檢測，以確保無不良微生物 (21 CFR 211.165(b))。

You manufacture multiple (b)(4) homeopathic drug products. Some of these products can be used to (b)(4). Additionally, some products may be used (b)(4).
[中譯] 您製造多種 (b)(4) 同類療法藥品。其中部分產品可用於 (b)(4)，此外部分產品也可能用於 (b)(4)。

Your firm released your finished homeopathic drug products without testing for microbiological attributes (e.g., total count, objectionable microorganisms). Without testing each batch prior to release, you did not have scientific evidence that all drug product batches were free of objectionable microbial contamination.
[中譯] 貴公司在放行同類療法成品藥品時，未進行微生物屬性檢測。若未在放行前對每批產品進行檢測，您便缺乏科學證據來證明所有藥品批次皆無不良微生物污染。

Your firm failed to conduct testing for (b)(4) for non-sterile (b)(4) drug products prior to release and at appropriate intervals for stability. See FDA’s guidance document, Microbiological Quality Considerations in Non-sterile Drug Manufacturing, for help minimizing the risks of harmful microbiological contamination of (b)(4) drugs at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microbiological-quality-considerations-non-sterile-drug-manufacturing.
[中譯] 貴公司未能在放行前及穩定性試驗的適當區間內，針對非無菌藥品進行 (b)(4) 測試。請參閱 FDA 指南以協助降低微生物污染風險。

Drug products that do not meet quality standards can pose a safety risk to the public.
[中譯] 不符合品質標準的藥品會對公眾構成安全風險。

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 211.84(d)(6)).
[中譯] 2. 貴公司未能針對原料成分進行鑑別測試並確認其符合適當的書面規格，亦未能定期驗證供應商檢驗分析的可靠性。同時也未能在使用前對具有潛在微生物污染風險的成分進行檢測 (21 CFR 211.84(d))。

You failed to perform adequate testing for purity, strength, quality, and identity for the components used in the manufacture of your (b)(4) drug products. In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.
[中譯] 您未能對用於製造藥品的成分進行充分的純度、強度、品質與鑑別測試。此外，您過度依賴供應商的分析證明 (COA)，卻未驗證其可靠性。

(b)(4)You failed to test your purchased bulk (b)(4) to assure it was of acceptable quality for use in drug production. You also failed to establish the reliability of your component supplier at appropriate intervals. Your firm has not demonstrated that the (b)(4) was suitable for its intended use, tested for microbiological quality, and minimally met the United States Pharmacopeia (USP) (b)(4) monograph.
[中譯] 您未能測試採購的散裝原料以確保其品質可接受，也未能證明該原料適合其預期用途、經過微生物品質測試，並至少符合美國藥典 (USP) 專論。

(b)(4) must be suitable for its intended use. Each lot must be tested to ensure conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts as well as characterization and identification of contamination is integral to ensuring (b)(4) is of acceptable quality for use in manufacturing operations.
[中譯] 該原料必須適合其預期用途，且每批次都必須進行測試。常規監測微生物數量以及污染的定性與鑑別，對於確保其品質至關重要。

Of note, you did not test the (b)(4) for (b)(4), a contamination risk in (b)(4) drug products, which has been linked to (b)(4). For further information regarding the significance of (b)(4) contamination of (b)(4) drug products, see FDA’s advisory notice at (b)(4).
[中譯] 值得注意的是，您並未針對該原料進行特定的污染風險測試，該風險與產品污染有關聯。詳細資訊請參閱 FDA 諮詢公告。

Ingredients at Risk for (b)(4) Contamination
[中譯] 具有 (b)(4) 污染風險的成分

You failed to adequately test your incoming components at high risk of (b)(4) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of (b)(4) to determine its appropriate identity. The identity testing of (b)(4) includes a limit test, according to the USP, to ensure that the component meets the relevant safety limits for the levels of (b)(4).
[中譯] 您未能在使用具有高污染風險的進料成分製造藥品前，對其進行充分的鑑別測試。這包含依據 USP 執行極限測試，以確保成分符合相關的安全標準限制。

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).
[中譯] 使用受污染的成分已在全球造成多起致命的人類中毒事件。請參閱 FDA 指南文件。

Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products.
[中譯] 若未對成分進行適當測試，您將無法確保藥品的品質與安全。

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).
[中譯] 3. 貴公司的品質管制單位未能履行其職責，以確保所製造之藥品符合 CGMP 及既定規格 (21 CFR 211.22)。

Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure:
[中譯] 您的品質單位未能充分監督製造作業。例如，未能確保：

Procedures were established or followed (21 CFR 211.22(d))
[中譯] 程序之建立與遵循 (21 CFR 211.22(d))

Batch records were reviewed before drug product release (21 CFR 211.22(a))
[中譯] 放行前審查批次紀錄 (21 CFR 211.22(a))

Adequate production and process controls were established (21 CFR 211.100(a))
[中譯] 建立適當的生產與製程管制 (21 CFR 211.100(a))

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.
[中譯] 貴公司的品質系統並不完善。請參閱 FDA 關於藥品 CGMP 規範的品質系統方法指南。

Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.
[中譯] 在製藥過程中不當使用人工智慧

During the FDA inspection of your drug manufacturing facility, you stated to FDA investigators that you utilized artificial intelligence (AI) agents (b)(4) to help your firm comply with FDA regulations. Specifically, you used AI to create drug product specifications, procedures, and master production or control records to be in compliance with FDA requirements.
[中譯] 查廠期間，您表示使用 AI 代理程式協助法規遵循，具體而言，您使用 AI 來建立產品規格、程序以及主製造或管制紀錄。

If you use AI as an aid in document creation, you must review the AI generated documents to ensure they were accurate and actually compliant with CGMP. Your failure to do so is a violation of 21 CFR 211.22(c). Overreliance on artificial intelligence for your drug manufacturing operations was also documented during the inspection. For example, the FDA investigators found that you had not conducted process validation prior to distribution of your drug products, as required under 21 CFR 211.100, and informed you as such. You replied that you were not aware of the legal requirement, as the AI agent you used (b)(4), never told you it was required.
[中譯] 若您使用 AI 協助文件製作，您必須審查這些 AI 生成的文件以確保其準確且符合 CGMP。您未執行此步驟已違反 21 CFR 211.22(c)。查廠也記錄了對 AI 的過度依賴：您甚至回應表示不知道製程確效的法律要求，因為「AI 代理程式從未告知」。

We recognize that you have ceased drug production. If you plan to resume drug production, and use AI to help with CGMP activities, such as development of procedures and specifications, any output or recommendations from an AI agent must be reviewed and cleared by an authorized human representative of your firm’s QU in accordance with section 501(a)(2)(B) of the FD&C Act. See also 21 CFR 211.22; 21 CFR 211.100.
[中譯] 任何來自 AI 代理程式的產出或建議，都必須由貴公司品質單位中經授權的人員代表進行審查與放行。

Drug Production Ceased
[中譯] 停止藥品生產

We acknowledge your commitment to cease production and distribution of drugs at this facility.
[中譯] 我們確認您承諾停止在該設施的藥品生產與配銷。

Even though you indicated your firm is no longer manufacturing products at your facility, there are still products within expiry in U.S. distribution. Data is required to support whether your components and your drug products meet established specifications (such as identity, strength, quality, and purity) and that these drug products will remain within acceptable limits and retain their quality attributes through their labeled shelf-life until expiry.
[中譯] 即便已停止生產，美國市場上仍有在效期內的產品。必須提供數據以證明這些產品在效期內符合既定規格並維持其品質屬性。

In response to this letter:
[中譯] 作為對此信件的回應：

Specify by National Drug Code (NDC) number which drugs have been discontinued and the last day of manufacture.
[中譯] 以 NDC 號碼指明哪些藥品已停產及最後製造日期。

Clarify your intentions for the drug products that remain on the market within expiry.
[中譯] 釐清對市場上仍在效期內藥品的處置意向。

o Explain how distributed drug products will be verified to ensure they meet specifications.
[中譯] o 解釋將如何驗證已配銷之藥品以確保其符合規格。

o Confirm that if you receive any client or customer complaints and/or any results from ongoing testing or evaluation that reveal substandard quality for the drug components, active pharmaceutical ingredient (API), or distributed drug products, that rapid corrective action should be taken for products that were released for commercial distribution and that are still within expiry, such as notifying customers and product recalls.
[中譯] o 確認若收到任何投訴或測試結果顯示品質不佳，將對效期內產品採取快速的矯正措施 (CAPA)，例如通知客戶與產品回收。

Provide commitment that if you intend to resume manufacturing drugs at this facility or any other facility in the future, that you will notify this office prior to resuming your drug manufacturing operations.
[中譯] 承諾未來若打算恢復製造，將在恢復營運前通知本辦公室。

If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, 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 all corrective action and preventive action, before you pursue resolution of your firm’s compliance status with FDA.
[中譯] 若恢復 CGMP 活動，您必須聘請合格顧問 (依據 21 CFR 211.34) 協助解決缺失。該顧問應執行全面的六大系統稽核，並評估所有矯正與預防措施的功效。

Owner’s Responsibilities
[中譯] 業主的責任

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
[中譯] 藥品必須符合 CGMP 規範。FDA 將合約商視為製造商的延伸。

You are responsible for the quality of your drugs regardless of agreements in place with a contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
[中譯] 無論與合約廠的協議為何，您都必須對藥品品質負責，以確保安全性、鑑別、強度、品質與純度。

Updates to the Electronic Drug Registration and Listing System (eDRLS)
[中譯] 更新電子藥品註冊與列名系統 (eDRLS)

If your firm does not intend to engage in any further drug manufacturing activities, then you, as the owner and operator of the drug manufacturing establishment, are required to update all outdated information to avoid miscommunication or errors. Consequently, your firm will need to modify the drug product marketing status and delist each product with the last lot expiry date as the “marketing end date” on the specific product listing per 21 CFR 207.57(b)(1)(ii).
[中譯] 若不再從事製造，您必須更新過時資訊，修改藥品行銷狀態並將產品除名。

Additionally, after delisting your drug products, you will need to deregister your overall drug establishment with FDA if you cease manufacturing and distributing drugs in U.S. per 21 CFR 207.29(a)(1). If you have any further registration or listing questions, please contact the EDRLS general mailbox: eDRLS@fda.hhs.gov.
[中譯] 此外，在美國停止製造與配銷後，您必須註銷整體藥品機構的註冊。

Unapproved New Drugs
[中譯] 未經核准之新藥

Based on a review of the product labels collected during the inspection, "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" 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 of claims from the product labels that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but are not limited to, the following:
[中譯] 基於標籤審查，這些產品被歸類為藥品，因為它們旨在用於診斷、治癒、緩解、治療或預防疾病。

Dermveda Extra Strength Shingles Relief
[中譯] Dermveda 強效帶狀皰疹舒緩

"SHINGLES"
[中譯] 「帶狀皰疹」

Dermveda Extra Strength Ultra Genital Herpes Relief
[中譯] Dermveda 強效生殖器皰疹舒緩

"GENITAL HERPES RELIEF"
[中譯] 「生殖器皰疹舒緩」

"Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
[中譯] 這些產品屬於「新藥」，因為它們尚未被普遍認為是安全且有效的 (GRASE)。由於這些產品並未獲得 FDA 批准的申請，它們是未經核准的新藥。將其引入州際貿易違反了聯邦法規。

We recognize that "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term "drug" includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.
[中譯] 我們理解這些產品被標示為同類療法藥物。然而，同類療法藥品需遵守與其他藥品相同的法規要求，且不能豁免於摻偽、標示不實或 FDA 批准的相關規定。

Cosmetics Manufactured for Distribution in the United States
[中譯] 在美國製造與配銷的化妝品

In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that 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.
[中譯] 此外，您生產的部分產品可能被歸類為化妝品。您製造的任何化妝品都必須遵守適用的法規要求。引入摻偽或標示不實的化妝品是違法行為。

We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.
[中譯] 2022 年化妝品法規現代化法案 (MoCRA) 提供了製造化妝品設施必須遵守的新要求。

Conclusion
[中譯] 結論

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.
[中譯] 本信中所提及的違規事項並非涵蓋貴廠所有違規情況的完整清單。您有責任調查並確定任何違規的原因，並防止其再次發生。

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.
[中譯] 請迅速糾正違規行為。若未能妥善處理，可能導致扣押與禁制令等法律行動。未解決的違規也可能影響聯邦合約的授予。

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.
[中譯] FDA 也可能暫停核發出口證明，或暫停批准列有貴公司的新藥申請，直到確認您符合 CGMP 為止。我們可能會重新查核以驗證矯正措施。

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.
[中譯] 收到此信後，請於 15 個工作日內以書面回覆本辦公室。說明您已採取哪些措施以解決並防止違規重演。若無法如期完成，請說明延遲原因與完成時程。

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3011669383 and ATTN: Frank Wackes.
[中譯] 請將電子回覆寄至指定信箱，並註明您的 FEI 編號。

Sincerely,/S/
[中譯] 誠摯地，/S/

Francis Godwin
[中譯] Francis Godwin

Director
[中譯] 主任

Office of Manufacturing Quality
[中譯] 製造品質辦公室

Office of Compliance
[中譯] 法規遵循辦公室

Center for Drug Evaluation and Research
[中譯] 藥品評估與研究中心

/S/
[中譯] /S/

Tina Smith
[中譯] Tina Smith

Captain, U.S. Public Health Service
[中譯] 美國公共衛生局上尉

Director
[中譯] 主任

Office of Unapproved Drugs & Labeling Compliance
[中譯] 未經核准藥品與標籤遵循辦公室

Office of Compliance
[中譯] 法規遵循辦公室

Center for Drug Evaluation and Research
[中譯] 藥品評估與研究中心