FDA Cites Sterile Injectable CGMP Violations at Fresenius Kabi Facility

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FDA issued a warning letter to Fresenius Kabi AG after a January 27 to February 18, 2026 inspection identified significant CGMP violations at its Melrose Park sterile injectable facility. FDA cited inadequate investigations of endotoxin and bioburden signals, media fill failures, complaints, and biological particulate contamination; deficient aseptic process simulations and cleanroom practices; and inadequate visual inspection, facility, and equipment controls. The letter states that investigations overrelied on passing finished-product tests and lacked supported root causes, broad scope, and CAPA effectiveness checks. It also describes recalls of three famotidine injection batches and, following FDA discussions, six batches of other injectable products. FDA requested independent assessments, retrospective reviews, remediation plans, and a response within 15 business days.

PIC/S Revises GMP Guide Annex 19 on Reference and Retention Samples

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PIC/S revised its GMP Guide for Medicinal Products to version PE 009-18, incorporating the revised Annex 19 on reference and retention samples. The revision primarily concerns Section 9, addressing samples for parallel imported, parallel distributed, and parallel traded products. A note specifying that Section 9 applies only where these activities are covered by local legislation has been retained. The PIC/S Committee adopted the revision by written procedure on 22 September 2026. PE 009-18 enters into force on 24 September 2026, coinciding with the revised EU Annex 19. Non-EEA PIC/S Participating Authorities and Applicants have been invited to transpose Annex 19 into their GMP Guides.

EMA Announces First Bilateral Meeting with APIC

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EMA announced its first bilateral meeting with the Active Pharmaceutical Ingredients Committee (APIC), organised within EMA’s annual bilateral meetings with industry stakeholder organisations. The meeting is scheduled for 2 September 2026 from 15:30 to 17:30 CEST at EMA in Amsterdam, the Netherlands. Its stated purpose is to exchange views and promote dialogue on topics of common interest. Participation is by invitation only. The page lists an agenda, first published on 31 July 2026 and updated on 23 September 2026, and a highlights report, reference EMA/199326/2026, first published on 23 September 2026.

FDA Warning Letter: Aseptic Processing and Media-Fill Deficiencies at Empower Pharmacy

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FDA states that its November 3-14, 2025, inspection found Empower Pharmacy’s compounded semaglutide and tirzepatide products did not meet section 503A conditions, making the ineligible products subject to CGMP. Investigators observed that sterile products were prepared under insanitary conditions. Smoke studies did not adequately demonstrate unidirectional airflow under dynamic conditions, and media fills were not conducted under the most challenging conditions. FDA also cited inadequate maintenance systems for equipment controlling aseptic conditions, deficient procedures to prevent microbiological contamination and validate aseptic and sterilization processes, inadequate environmental monitoring, insufficient production and process-control procedures, and failure of the quality control unit to ensure CGMP compliance and product specifications. In reviewing corrective actions, FDA said a revised smoke study remained unfinalized. It also identified unexplained vial-count discrepancies, missing or unclear media-fill records, undefined “N/A” entries, and transcription of original results onto a revised form without a clear audit trail, authorization, or justification.

FDA Warning Letter: KDC/ONE Chatsworth cited for testing, OOS investigation, and storage deficiencies

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FDA inspected KDC/ONE Chatsworth’s drug manufacturing facility from March 31 to April 3, 2026, and cited significant CGMP violations involving OTC finished pharmaceuticals. The agency states that the firm lacked scientifically sound finished-product specifications and did not perform specified contaminant testing at release or during stability studies, despite known degradation and reaction pathways and notification of contamination linked to products recalled in Canada. FDA said the firm did not determine whether recalled batches reached the United States, assess U.S. consumer risk, identify other potentially affected batches, or demonstrate that its proposed third-party laboratory was qualified. FDA also observed inadequate investigations of viscosity OOS stability results, including insufficient root-cause determination, CAPA, specification justification, and risk assessment for distributed products. In addition, FDA found inadequate warehouse temperature monitoring and procedures, including storage above labeled conditions and internal limits. FDA considered the firm’s responses inadequate and stated that the quality unit was not able to fully exercise its authority and responsibilities.

Par Health Recalls Two Dexmedetomidine Injection Lots for Particulate Matter

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Par Health announced a voluntary nationwide recall to the hospital level of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL, after particulate matter was identified as cellulose or stopper material. The affected lots are 87558, expiring February 2027, and 88802, expiring April 2027. They were distributed to wholesalers between May 13 and June 29, 2025. Wholesalers and hospital pharmacies were instructed to stop use and distribution and return existing inventory. The announcement states that particulate administration could cause life-threatening vascular consequences. No related adverse events had been reported.

Otsuka ICU Medical Recalls Sodium Chloride Injection Lot for Potential Potassium Chloride Mix-Up

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Otsuka ICU Medical LLC announced a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, after a customer complaint identified a potential product mix-up. Sodium chloride overwraps from lot 1042188, NDC 0990-7984-23, may contain 10-mEq Potassium Chloride Injection bags from lot 1035181. The affected lot was manufactured on November 13, 2025, distributed in the United States from December 30, 2025, through June 22, 2026, and expires October 31, 2027. The company reported no related adverse events to date. Customers and distributors were instructed to inspect inventory, quarantine and discontinue use, and return affected product.

FDA Announces Year Five of the CMC Development and Readiness Pilot

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FDA states that it will begin accepting requests on October 1, 2026, for year five of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot. The program supports selected CBER- and CDER-regulated products under investigational new drug applications with accelerated clinical development timelines. Accepted sponsors may discuss CMC product development strategies and goals with FDA review staff during two predesignated Type B meetings, with follow-up discussions available for questions or clarification. FDA will select no more than nine proposals per year. Participation requests must be submitted as IND amendments with the specified cover-letter statement. The pilot will continue through fiscal year 2027.

FDA Human Drug Compounding Information and Oversight Resources

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FDA describes human drug compounding as the combining, mixing or altering of drug ingredients by specified licensed professionals, or supervised personnel at an outsourcing facility, to create medication tailored to an individual patient’s needs. It states that compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness or quality before marketing. FDA says its compounding program seeks to protect patients from poor-quality compounded drugs while preserving access to lawfully marketed products for patients with medical need. The page provides links on laws, policies, risk alerts, bulk drug substances, outsourcing facilities, registrations, inspections, recalls, state information and the Compounding Quality Center of Excellence.

FDA Warning Letter: Bausch & Lomb cited for aseptic processing and contamination-control deficiencies

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FDA states that its March 12–20, 2026 inspection of Bausch & Lomb’s Tampa drug manufacturing facility identified significant CGMP violations involving sterile prescription and OTC products. Environmental and personnel monitoring did not sufficiently cover significant locations, procedures were inadequate, and cracked media could not adequately support growth of recovered contamination. From 2023 to 2025, the firm routinely recovered out-of-limit microorganisms in ISO 5 areas, including gram-negative organisms associated with water sources, but continued production without adequate CAPA. FDA also cited inadequate investigations of microbiological departures and adverse trends, insufficient microorganism identification, RABS and barrier-design deficiencies, and smoke studies that did not sufficiently demonstrate unidirectional airflow. Operators were repeatedly observed using poor aseptic techniques during filling. Media fills were substantially smaller than commercial batches and did not adequately represent contamination risks; a July 2025 media fill failed with fungal and spore-forming bacterial contamination. FDA further stated that management oversight was ineffective and the quality unit lacked sufficient authority or implementation of its responsibilities.