Supply Chain / Shortages

FDA Warns Kellin Chemicals Over Refused API Facility Inspection

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FDA issued a warning letter to Kellin Chemicals (Zhangjiagang) Co., Ltd., an establishment registered as an active pharmaceutical ingredient supplier to finished-drug manufacturers serving the U.S. market. The firm’s U.S. agent told FDA that the company refused a preannounced inspection planned for July 7–11, 2025. FDA states that drugs made, processed, packed, or held there are adulterated under section 501(j) because inspection was refused. FDA may withhold application or supplement approvals listing the facility and may detain or refuse relevant U.S. shipments. The company was asked to respond within 15 working days and could request an inspection.

FDA Compounding Policy and Rule Resources Updated Through September 2026

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The FDA page compiles policy documents and related materials governing human drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Its latest listed item is final guidance dated September 4, 2026 on temporary policies for compounding certain starter parenteral nutrition drug products for neonates. It also lists an April 30, 2026 Federal Register notice on the section 503B clinical-need list for bulk drug substances, with an FDA statement proposing exclusion of semaglutide, tirzepatide, and liraglutide. Earlier entries cover bulk substances, temporary parenteral compounding policies, outsourcing facilities, insanitary conditions, current good manufacturing practice, reporting, distribution, and repackaging. The page identifies its content as current as of September 9, 2026.

EMA Guidance on Implementing Shortage Prevention Plans

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EMA issued guidance describing how marketing authorisation holders should establish, maintain and update Shortage Prevention Plans for prescription-only human medicines in EU/EEA countries. Plans may group products sharing a supply chain, provided product-level minimum data can be supplied within two days of a request. The guidance sets out product information, patient-impact assessment, supply-chain mapping, shortage history, risk classification and proportionate management measures. It also identifies additional crisis-related information for listed critical medicines, including production and supply capacity, alternative sites and minimum stock levels. Plans should be updated after relevant changes and may form part of annual product quality review.

FDA and PDA Announce 2026 Joint Regulatory Conference

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FDA and the Parenteral Drug Association (PDA) will host the 2026 PDA/FDA Joint Regulatory Conference, “Excellence in CGMP: Ensuring Quality, Protecting Patients,” in Washington, D.C., from September 14 through 16, 2026. The program is intended to provide practical insights on CGMP compliance, quality systems, risk-based manufacturing, supply chain oversight, and industrial modernization through expert discussions and case studies. Listed subjects include FDA center and office updates, artificial intelligence in regulatory oversight and inspection readiness, pre-approval inspections, CAPA and effectiveness checks, data governance, quality risk management, change management, workforce development, CGMP training, and global regulatory collaboration. Registration and a full agenda are available through PDA.