{"filing":{"accession_number":"0001297184-26-000041","cik":"0001297184","ticker":"AMPH","company_name":"Amphastar Pharmaceuticals, Inc.","form":"8-K","filing_date":"2026-07-07","report_date":null,"primary_document":"amph-20260702x8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1297184/000129718426000041/amph-20260702x8k.htm"},"events":[{"id":16558,"run_id":14793,"accession_number":"0001297184-26-000041","anchor_item_number":"8.01","event_type":"legal_other","event_domain":"legal","is_material":true,"confidence":0.85,"summary":"The disclosure centers on an FDA Warning Letter issued to IMS (a subsidiary) on July 2, 2026, citing CGMP violations at its South El Monte manufacturing facility. This is a regulatory enforcement action that could materially impact the company's ability to manufacture and distribute products. While the Warning Letter does not currently direct cessation of production, the company acknowledges uncertainty about FDA satisfaction with remediation efforts and the possibility of \"additional regulatory or legal action\" without further notice, creating material regulatory and operational risk.","company_name":"Amphastar Pharmaceuticals, Inc.","ticker":"AMPH","filing_date":"2026-07-07","form":"8-K","submitted_at":null,"items":[{"id":14698,"accession_number":"0001297184-26-000041","item_number":"8.01","item_title":"Other Events","event_type":"legal_other","event_domain":"legal","is_material":true,"confidence":0.85,"reasoning":"The disclosure centers on an FDA Warning Letter issued to IMS (a subsidiary) on July 2, 2026, citing CGMP violations at its South El Monte manufacturing facility. This is a regulatory enforcement action that could materially impact the company's ability to manufacture and distribute products. While the Warning Letter does not currently direct cessation of production, the company acknowledges uncertainty about FDA satisfaction with remediation efforts and the possibility of \"additional regulatory or legal action\" without further notice, creating material regulatory and operational risk.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-08T10:04:09.380914+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":14698,"accession_number":"0001297184-26-000041","item_number":"8.01","item_title":"Other Events","event_type":"legal_other","event_domain":"legal","is_material":true,"confidence":0.85,"reasoning":"The disclosure centers on an FDA Warning Letter issued to IMS (a subsidiary) on July 2, 2026, citing CGMP violations at its South El Monte manufacturing facility. This is a regulatory enforcement action that could materially impact the company's ability to manufacture and distribute products. While the Warning Letter does not currently direct cessation of production, the company acknowledges uncertainty about FDA satisfaction with remediation efforts and the possibility of \"additional regulatory or legal action\" without further notice, creating material regulatory and operational risk.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-08T10:04:09.380914+00:00","company_name":"Amphastar Pharmaceuticals, Inc.","ticker":"AMPH","filing_date":"2026-07-07"}]}