GMP News

FDA Warning Letter: Reliance Life Sciences cited for data integrity and aseptic processing deficiencies

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FDA’s February 19–27, 2026 inspection of Reliance Life Sciences’ Navi Mumbai drug facility identified significant CGMP violations involving laboratory data, sterile manufacturing, and quality oversight. FDA found environmental monitoring and other microbiology samples recorded as collected and incubated even though plates were absent and analysts confirmed the samples were not collected. LIMS calculations omitted required dilution factors, while electronic integrity-testing files lacked unique names and were overwritten; testing was also not performed for one plant. FDA said these deficiencies created a risk of underreported microbial findings and unreliable batch-release evidence. In aseptic operations, investigators observed operators blocking unidirectional airflow over critical locations and not discarding potentially compromised vials. FDA also observed deteriorated or damaged manufacturing areas or components, excess sealant near HEPA filters, nonsterile wipes used for cleaning, and standing water and staining near pipelines. FDA deemed the firm’s responses insufficient, citing incomplete remediation detail, traceability, oversight, and timelines. The company agreed to recall all sterile drugs and suspend U.S.-market production; FDA later placed its drugs on Import Alert 66-40.

FDA Warning Letter: PReye cited for unsuitable aseptic processing and inadequate quality systems

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FDA states that its March 17–19, 2026, inspection of PReye’s drug manufacturing facility found significant finished-pharmaceutical CGMP violations. The firm manually filled multiple drug products from bulk liquid using a small flow hood on an office desk. FDA observed that the hood was neither certified nor qualified and was located in unclassified office space without HEPA filtration. FDA stated that these conditions lacked appropriate facilities, equipment, and process controls to protect products from microbiological contamination. FDA also found no quality unit function or written procedures defining its responsibilities. Basic procedures were absent, including complaint review, supplier qualification, release testing, change management, cleaning, disinfection, and deviation handling. FDA further reported missing batch numbers for sterile ophthalmic products manufactured since 2024, impairing traceability. The firm committed to cease U.S. manufacturing and distribution of PReye Vitamin SEE; it later voluntarily recalled the product because sterility testing had not been performed.

FDA Warning Letter: Insanitary API Manufacturing, Incomplete Laboratory Data, and Weak Quality Oversight

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FDA states that its April 13 to 17, 2026 inspection of Shoolin Pharma Chem LLP found APIs prepared, packed, or held under insanitary conditions and identified significant API CGMP violations. Investigators observed layered unidentified residues, chemical residues and stains on walls, floors, equipment, and product-contact areas; corroded or apparently rusted surfaces; leaking lines; improperly stored transfer lines; and an employee wearing open-toed sandals near open equipment during production. Nondedicated equipment was used for multiple APIs. FDA also found inadequate written cleaning and maintenance procedures, no swab or rinse cleaning verification, and insufficient cleaning validation remediation. The firm could not provide raw data supporting certificate-of-analysis results, while contract-laboratory results were reported on company letterhead without identifying the original laboratory. Stability chambers were powered off or outside temperature or humidity conditions, supporting records were unavailable, and tadalafil samples were missing. FDA further cited inadequate quality-unit oversight of impurity risks, contract laboratories, process validation, equipment calibration, materials testing, and annual product reviews. The firm recalled all APIs distributed in the U.S., and FDA placed its drugs on Import Alert 66-40.

FDA Warning Letter: Fresenius cited for leaking dialysis solution bags and inadequate visual inspection controls

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FDA inspected Fresenius USA Manufacturing’s Ogden, Utah drug facility from March 2-6, 2026, and cited significant CGMP violations involving complaint investigations, CAPA, process controls, and visual inspection of sterile injectable products. For Delflex Peritoneal Dialysis Solution, an August 2025 investigation covered 35 complaints involving approximately 156 leaking bags from multiple batches and attributed holes to printing. FDA stated that the firm assigned the lowest severity despite its matrix identifying peritonitis as a potential harm at the highest severity, did not recall then, and inadequately investigated risk and implemented CAPA. After inspection, reexamination found perforations without substantial fluid in the overwrap; the firm reassessed risk and recalled affected lots on April 6, 2026 for lack of assurance of sterility. FDA found the response still lacked sufficient CAPA to improve leak detection. FDA also found personnel qualification for visual particulate inspection inadequate because the kit was not adequately representative and records lacked sufficient detail, and said the response did not demonstrate reliable detection at an appropriate level.

International regulators assess recombinant endotoxins testing protocol

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FDA states that, through the International Coalition of Medicines Regulatory Authorities Collaborative Assessment Pilot, it and regulators from Australia, Canada, Japan, Switzerland, and the European Medicines Agency jointly assessed a recombinant endotoxins testing approach for biological products. The method is an alternative to the horseshoe crab blood-dependent Limulus Amebocyte Lysate test. The submission used a Post-Approval Change Management Protocol covering several biological products across multiple therapy areas. The European Medicines Agency led the review, and the PACMP was approved in June 2026, with participating authorities reaching aligned decisions within days. FDA says the pilot coordinates questions and reviews while preserving independent decisions, aiming to improve consistency, reduce duplication, and support timely access.

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.

2024 PDA/FDA Conference Focuses on Effective Quality Systems

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FDA and the Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference on September 9–11, 2024, emphasizing effective quality systems and an ongoing state of control across the product lifecycle. The program focuses on robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management as foundations for CGMP compliance. It will use case studies to address sustainable compliance, quality and supply consistency, and international collaboration. Planned discussion topics include investigations, cybersecurity and data integrity risks, supplier selection and auditing, current manufacturing technologies, CGMP guidance updates, aging facilities, quality assurance authority, and quality-control laboratory risk reduction.

B. Braun Recalls Three Sodium Chloride Injection Lots for Zinc Oxide Particulates

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B. Braun Medical Inc. voluntarily recalled three lots of 0.9% Sodium Chloride Injection USP, 100 mL in 150 mL PAB® containers, nationwide at the hospital, healthcare facility, and user levels. The recall followed detection of particulate matter identified as zinc oxide. Affected lots are J6B435, J6B444, and J6B457, with expiration date 30APR2027; distribution occurred from February 27, 2026 through August 3, 2026. The company warned that intravenous administration could cause life-threatening vascular, immune, organ, or blood-cell effects. No serious injuries, deaths, or other adverse events had been reported. B. Braun is notifying distributors and customers and arranging returns and replacements.

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.

FDA Warning Letter: Spa De Soleil cited for water system, component testing, validation, and quality unit deficiencies

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FDA inspected Spa De Soleil’s Sun Valley drug manufacturing facility in January 2026 and found significant CGMP violations affecting OTC topical drug production. FDA states the firm inadequately investigated 51 water-system microbiological OOL and chemical OOS results recorded from May 2024 through July 2025, including gram-negative recoveries, conductivity failures, and total organic carbon failures. Investigations relied on resampling and retesting without identifying microorganisms or adequately evaluating affected products. The water system contained dead legs, threaded fittings, Teflon tape, and ball valves, and monitoring did not reflect production schedules. FDA also found inadequate identity and impurity testing of incoming high-risk components, including controls for methanol, DEG, and EG, plus unverified reliance on supplier certificates of analysis. Manufacturing processes lacked adequate validation, and batch records omitted critical processing parameters and equipment identification. An alternative microbiological method was not shown equivalent to or better than USP methods. FDA further cited ineffective quality-unit oversight, insufficient contract-laboratory qualification, absent annual product quality evaluations, and unvalidated cleaning procedures. The February 2026 response lacked supporting documentation and adequate corrective-action evidence; similar violations had been cited in 2021.