重大事件
即時報告
8-K
2026-07-08
Amphastar子公司IMS接FDA警告信 涉南艾爾蒙特廠生產違規
AI 繁中摘要
Amphastar Pharmaceuticals 子公司 IMS 於 2026 年 7 月 2 日收到 FDA 警告信 ⚠️，涉及南艾爾蒙特工廠的生產規範違規。
📄 **申報類型**：8-K（其他重大事件）
**事件概要**：
- 警告信源自 2025 年 12 月的 FDA 檢查，並附有 483 觀察報告。
- 違規涉及：調查程序、環境監測與處理程序、生產設備（CGMP 規範）。
- 警告信**未要求** IMS 停止生產或限制產品供應，亦無需進一步回收，但須待第三方核實。
- 公司需在 **15 個工作日** 內提交初步回應，並進行風險評估及提交補救方案。
**公司回應**：
- IMS 已於檢查後開始執行糾正行動，並持續從該設施生產供貨。
- 管理層正評估警告信對業務的潛在影響，但**無法保證** FDA 對回應滿意或具體解決時間表。
**對投資者的潛在影響**：
- 若未能在限期內糾正，FDA 可能採取進一步監管或法律行動（如停產、罰款等），影響公司營運及聲譽。
- 短期內產能未受限制，但合規成本及不確定性增加，或影響市場信心。
**前瞻性陳述**：公司提醒實際結果可能因法規變化、供應鏈中斷等因素而有重大差異，詳見公司年報（10-K）及季報（10-Q）。
展開英文正文
Amphastar Pharmaceuticals, Inc._July 2, 2026
0001297184false00012971842026-07-022026-07-02
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event Reported): July 2, 2026
Amphastar Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware
001-36509
33-0702205
(State or Other Jurisdiction of
Incorporation)
(Commission File Number)
(I.R.S. Employer Identification
Number)
11570 6th Street
Rancho Cucamonga, California
91730
(Address of Principal Executive Offices)
(Zip Code)
Registrant's telephone number, including area code: (909) 980-9484
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
T
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
AMPH
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events
On July 2, 2026, International Medication Systems, Limited (“IMS”), a subsidiary of the Company, received a warning letter (the "Warning Letter") from the FDA relating to IMS's drug manufacturing facility located in South El Monte, California. The Warning Letter follows an FDA inspection of the facility conducted in December 2025. The FDA issued inspectional observations at the conclusion of the inspection on an FDA Form 483.
The Warning Letter cites violations of current Good Manufacturing Practice ("CGMP") regulations for finished pharmaceuticals. The observations in the Warning Letter relate to investigation procedures, environmental monitoring and handling procedures, and manufacturing equipment. The Warning Letter does not direct IMS to cease or restrict products from the facility, nor does it require a further recall, although this is subject to third party verification. IMS continues to manufacture and supply products from the facility while implementing its remediation plan. The Warning Letter requests that IMS submit an initial response within 15 working days, conduct a risk assessment and submit a remediation plan.
The Company and IMS take the matters identified in the Warning Letter seriously. Since the conclusion of the inspection, IMS has implemented and is continuing to implement corrective actions in response to the Form 483 and Warning Letter. The Company is currently evaluating the impact of the Warning Letter on its business operations. The Company cannot, however, give any assurance that the FDA will be satisfied with IMS’s response or as to the timing of the resolution of the matters described in the Warning Letter. Until the deficiencies cited in the Warning Letter are resolved to the FDA's satisfaction, additional regulatory or legal action may be taken without further notice.
Forward-Looking Statements
All statements in this current report that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s receipt of the Warning Letter, including potential corrective actions and resolutions, as well as any additional regulatory or legal action that could be taken against the Company. These statements are not facts but rather are based on the Company’s historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including changes in laws and regulations and disruptions in supply chains as well as others described in the Company’s filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 26, 2026, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 7, 2026, and in our other filings or reports that we may file with the SEC. You can locate these reports through our website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. The forward-looking statements in this current report speak only as of the date of the report. The Company undertakes no obligation to revise or update information or any forward-looking statements in this current report to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AMPHASTAR PHARMACEUTICALS, INC.
Date: July 8, 2026
By:
/S/WILLIAM J. PETERS
William J. Peters
Chief Financial Officer, Executive Vice President and Treasurer