FDA就Kellin Chemicals张家港厂区拒绝预先通知检查发出警告信320-26-15
Kellin Chemicals Co., Ltd. - Zhangjiagang MARCS-CMS 716228 — November 06, 2025
FDA向Kellin Chemicals（张家港）公司发出警告信320-26-15，指其拒绝2025年7月7日至11日的预先通知检查。FDA称依据FD&C法案501(j)条款其药品被认定为掺假，并可能暂缓批准将该公司列为药品生产商的新申请或补充申请，相关货物可被扣留或拒绝入境。公司需在收到信后15个工作日内书面回复。
警告信记录该原料药供应商拒绝FDA预先通知的检查，并列出可能暂缓批准及扣留货物的处理依据。
WARNING LETTER
Kellin Chemicals Co., Ltd. - Zhangjiagang MARCS-CMS 716228 — November 06, 2025
- Delivery Method:
- Via Email Return Receipt Requested
- Product:
- Drugs
- Recipient:
-
Recipient Name
Zhiyu Du
-
Recipient Title
Marketing and Sales Center Representative
- Kellin Chemicals Co., Ltd. - Zhangjiagang
No. 5 Changjiang North Road
Yangzijiang Chemical Industrial Park
Zhenjiang Shi
Jiangsu Sheng, 215634
China
- Issuing Office:
- Center for Drug Evaluation and Research (CDER)
United States
Warning Letter 320-26-15
November 6, 2025
Dear Zhiyu Du:
Your firm is currently registered as a supplier of active pharmaceutical ingredients (API) (for example, (b)(4)) to manufacturers of finished drug products who have distributed to the U.S. market.
The United States Food and Drug Administration (FDA) notified your site, Kellin Chemicals (Zhangjiagang) Co., Ltd., FEI 3017343300, at No. 5 Changjiang North Road, Yangzijiang Chemical Industrial Park, Zhangjiagana, Jiangsu, of a planned inspection of your drug manufacturing facility from July 7 to July 11, 2025. Your United States (U.S.) Agent, Registrar Corp., notified us that your firm refused the preannounced inspection.
Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has delayed, denied, limited, and/or refused to permit inspection.
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Kellin Chemicals (Zhangjiagang) Co., Ltd., No. 5 Changjiang North Road, Yangzijiang Chemical Industrial Park, Zhangjiagana, Jiangsu, into the United States. that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
We recommend that you inform any U.S. customers of this letter. Introduction into interstate commerce of adulterated drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a); and receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, such as by drug product manufacturers using adulterated API as a component, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c).
After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.
Send your electronic reply to [email protected]. Identify your response with FEI 3017343300 and ATTN: Maria Pavco.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Cc: Registrar Corp
来源：FDA CDER CGMP Warning Letters · fda.gov