某国内药企因拒绝FDA检查收到了警告信！

2026年9月29日，FDA发布了Kellin Chemicals Co., Ltd. - Zhangjiagang（凯凌化工-张家港）的警告信， 原因是拒绝检查 。

检查对象：凯凌化工-张家港

计划检查日期：2025 年 7 月 7 日‑7 月 11 日

FDA 警告信日期：2025年11月6日

地址：江苏省镇江市张家港保税区扬子江化工园区长江北路5号

警告信原文及其翻译如下：

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.

贵司目前注册为原料药（API）（例如，(b)(4)）供应商，向已向美国市场开展分销的制剂成品生产企业供货。

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.

美国食品药品监督管理局（FDA）已通知贵司生产场所 —— 凯凌化工（张家港）有限公司（FEI 编号：3017343300，地址：江苏省张家港市扬子江化学工业园长江北路 5 号，计划于 2025 年 7 月 7 日‑7 月 11 日对贵司药品生产设施开展检查。贵司的美国代理机构 Registrar Corp. 向我方告知，贵司拒绝接受本次预先通知的检查。

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.

依据《联邦食品、药品和化妆品法案》（FD&C Act）第 501 (j) 条，即《美国法典》第 21 编 §351 (j)，贵司药品属于劣药，原因是该药品在设施内完成生产、加工、包装或储存，而该设施的所有者或运营方拖延、拒绝、限制和 / 或不允许开展检查。

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).

在 FDA 获准对贵司设施实施检查并确认其符合现行药品生产质量管理规范（CGMP）之前，对于任何将贵司列为药品生产企业的新申请或补充申请，我方可暂缓批准。此外，依据《联邦食品、药品和化妆品法案》第 801 (a)(3) 条，即《美国法典》第 21 编 §381 (a)(3)，由凯凌化工（张家港）有限公司（江苏省张家港市扬子江化学工业园长江北路 5 号）生产、发运至美国，且疑似属于劣药或标签不合规的货物，将面临扣留或拒绝入境处置。

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).

我方建议贵司将本函告知所有美国客户。将劣药投入州际商业流通，违反《联邦食品、药品和化妆品法案》第 301 (a) 条，即《美国法典》第 21 编 §331 (a)；在州际商业活动中接收劣药，并进行交付或拟进行交付（例如制剂生产企业将劣原料药作为组分投入使用），违反《联邦食品、药品和化妆品法案》第 301 (c) 条，即《美国法典》第 21 编 §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.

请贵司收到本函后，于 15 个工作日内向本部门作出书面回复。贵司在回函中，可提供补充 材料供我 方在持续评估贵司业务及生产行为时参考，同时 / 或提交申请，预约安排 FDA 现场检查。

根据FD&C法，任何工厂、仓库或经营场所所生产、加工、包装或储存的某药品，如该工厂、仓库或经营场所的所有人、经营者或代理人拖延、拒绝或限制检查，或者拒不允许进入或接受检查，则该药品即被视为劣药，并根据FD&C 法 第801(a)(3)条的规定，可能被拒绝入境。