{"url":"https://newsforagent.com/news/2026-11-02/chemexpress-maanshan-fda-inspection-report","markdown_url":"https://newsforagent.com/news/2026-11-02/chemexpress-maanshan-fda-inspection-report.md","title":"ChemExpress Ma'anshan Site Clears First FDA Inspection","headline":"ChemExpress Ma'anshan API Site Receives FDA Inspection Report With No Form 483 Observations","description":"ChemExpress's Ma'anshan site received its first FDA Establishment Inspection Report with no Form 483 observations.","section":"Regulation & Approvals","published_at":"2026-11-02T09:48:11+00:00","modified_at":"2026-11-02T09:48:11+00:00","author":"News Desk","key_takeaways":["ChemExpress's Ma'anshan site received an FDA Establishment Inspection Report with no Form 483 observations after an August 2026 inspection.","The inspection covered six cGMP systems for API manufacturing under Compliance Program CPGM 7356.002F.","Dr. Yonggang Chen, SVP and CTO of ChemExpress, said the outcome reinforces the company's responsibility to maintain quality and compliance standards."],"companies":[{"name":"U.S. Food and Drug Administration","is_primary":true,"profile_url":null,"website":"http://www.fda.gov"},{"name":"ChemExpress","is_primary":false,"profile_url":"https://akta.pro/company-profiles/00093pr/chemexpress","website":"http://www.chemexpress.com.cn/index.html"}],"source":{"publisher":"EIN Presswire","title":"No Form FDA 483 Observations in First U.S. FDA Inspection of ChemExpress’ Ma’anshan Site","url":"https://www.einnews.com/pr_news/953358274/no-form-fda-483-observations-in-first-u-s-fda-inspection-of-chemexpress-ma-anshan-site"},"other_sources":[{"publisher":"news.cision.com","url":"https://news.cision.com/qlife-holding-ab/r/qlife-receives-iso-13485-certification-specifically-covering-at-home-testing-for-phenylalanine--phe-,c4414219"},{"publisher":"Jiemian","url":"https://www.jiemian.com/article/15273537.html"}],"tags":["Regulation & Approvals","U.S. Food and Drug Administration","ChemExpress"],"body_markdown":"ChemExpress's Ma'anshan site has received a U.S. Food and Drug Administration Establishment Inspection Report with no Form 483 observations following the site's first FDA inspection, conducted in August 2026. [EIN Presswire](https://www.einnews.com/pr_news/953358274/no-form-fda-483-observations-in-first-u-s-fda-inspection-of-chemexpress-ma-anshan-site) reported the milestone on November 2, 2026. The site is operated by Anhui Haoyuan Pharmaceutical Co., Ltd., a wholly owned subsidiary of [ChemExpress](https://akta.pro/company-profiles/00093pr/chemexpress), a Shanghai-based contract development and manufacturing organization.\n\n## What the FDA Inspection Covered at Ma'anshan\n\nThe inspection was carried out under the FDA's Fiscal Year 2026 work plan and Compliance Program CPGM 7356.002F, Active Pharmaceutical Ingredient Process Inspection, using a systems-based approach. Investigators evaluated six key cGMP systems: Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control. The review also assessed manufacturing operations for APIs and pharmaceutical intermediates intended for human drug products supplied to the U.S. Market.\n\nThe Ma'anshan site, formally the Taodian Avenue Division, focuses on API and highly potent API CDMO services spanning process scale-up, cGMP manufacturing and commercial supply. Dr. Yonggang Chen, SVP and CTO of ChemExpress, said: \"Successfully completing our first U.S. FDA inspection with no Form FDA 483 observations is an important milestone in ChemExpress' Ma'anshan Site's ongoing development of an internationally aligned quality management system.\" Chen added that the company will continue strengthening its quality systems in line with international cGMP standards.\n\n## ChemExpress's Path to the Ma'anshan Inspection\n\nChemExpress's announcement follows a run of FDA regulatory activity across the sector in recent months. On September 21, 2026, PureTech announced completion of an End-of-Phase 1 meeting with the FDA and Fast Track designation for LYT-200 in relapsed or refractory high-risk myelodysplastic syndromes, FinancialContent Business Page reported. On September 24, 2026, Eli Lilly received FDA approval for Onswik, a once-weekly basal insulin for adults with type 2 diabetes, based on QWINT Phase 3 trials with more than 3,400 participants, PR Newswire reported.\n\n## Quality Certifications Elsewhere in the Sector\n\nOther companies have also reported quality and regulatory milestones. Qlife received ISO 13485 certification covering its at-home blood testing solution for phenylalanine on October 23, 2026, [news.cision.com](https://news.cision.com/qlife-holding-ab/r/qlife-receives-iso-13485-certification-specifically-covering-at-home-testing-for-phenylalanine--phe-,c4414219) reported. On October 30, 2026, China's National Medical Products Administration issued revised guidelines for independent software inspection of medical device production quality management, effective November 1, 2026, [Jiemian](https://www.jiemian.com/article/15273537.html) reported.\n\n## ChemExpress's Next Steps After the Inspection\n\nChemExpress said it will continue strengthening its quality management systems in alignment with international cGMP requirements and expand its CDMO services across global regulated markets. The company said the inspection outcome supports future API, HPAPI and related CDMO projects for customers targeting regulated markets.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}