Deviations / Investigations

FDA Warning Letter: Baxter cited for cross-contamination and aseptic control failures

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FDA states that its March 23–April 2, 2026, inspection of Baxter Healthcare Corporation’s Round Lake drug facility found significant CGMP violations in sterile injectable manufacturing. The facility did not achieve complete separation between cephalosporin and other drug production: environmental monitoring repeatedly detected cephalosporin outside the beta-lactam area, while sampling locations, swab recovery qualification, sample timing, and finished-product sampling were inadequate. Multiple failing environmental samples were mistakenly discarded. FDA also identified deficient aseptic controls, including recurring biological indicator growth accepted during requalification, insufficiently representative media fills, inadequate ISO 5 environmental monitoring, incomplete airflow visualization studies, and turbulent non-unidirectional airflow around processing equipment. Manual visual inspection was unreliable because operator qualification, challenge particles, and inspection speed were inadequate; particulate complaints included confirmed cardboard contamination. Investigations into rising container-closure leaks and a 2025 cefazolin sterility failure were also inadequate, and the sterility result was invalidated without adequate scientific justification before lot release. FDA found the company’s responses insufficient and its quality systems inadequate.

FDA Warning Letter: Rohto cited for falsified monitoring records and aseptic processing failures

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FDA’s April 2026 inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. identified significant CGMP violations in the manufacture of aseptically processed OTC ophthalmic drugs. FDA observed systemic falsification of environmental monitoring, personnel monitoring, and cleaning records, including submission of unexposed plates and documentation of cleaning that management confirmed was not performed. After FDA discussed these deficiencies with management, monitoring conducted during the inspection produced numerous samples with microbial growth, including approximately 25 ISO 5 excursions. FDA also observed poor aseptic practices, undocumented interventions, deficient gowning, reuse of opened sterile component bags, infrequent decontamination, inadequate supervisory oversight, and equipment placement that obstructed unidirectional airflow. Investigations of two batches exceeding visual-inspection reject limits did not adequately identify the nature or source of particles, yet the batches were released to the U.S. market. FDA found the company’s response inadequate, citing reliance on unreliable monitoring data and insufficient consideration of systemic data integrity failures. The company subsequently initiated recalls due to lack of sterility assurance and suspended U.S.-market production.

FDA Warning Letter: SCA Pharmaceuticals cited for aseptic processing and contamination-control deficiencies

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FDA states that its October 20–30, 2025, inspection of SCA Pharmaceuticals’ Little Rock outsourcing facility found serious deficiencies in production of drugs intended or expected to be sterile. Investigators cited inadequate certification and dynamic airflow visualization of ISO 5 areas, airflow and HEPA-supplied positive-pressure concerns, poor aseptic practices, deficient material disinfection, and environmental monitoring that was not representative of production conditions. FDA also found inadequate evaluation of microbial contamination in ISO 5 areas and insufficient investigations, CAPA, and batch-impact assessments. Component and visual inspection controls did not adequately identify, classify, investigate, trend, or address particles and foreign material between syringe stopper ribs. Laboratory controls and Quality Unit procedures were cited as inadequate. Production videos used in investigations were overwritten after approximately a redacted period, with only still images retained. FDA found some responses deficient and could not fully evaluate others because supporting documentation was inadequate, and recommended a comprehensive aseptic operations assessment assisted by a qualified sterile-manufacturing consultant.

FDA Warning Letter: Microbiological Data and Quality Unit Deficiencies at Eurofins SF Analytical Laboratories

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FDA states that its June 1–3, 2026 inspection of Eurofins SF Analytical Laboratories’ contract testing facility identified significant finished-drug CGMP violations in microbiological testing and quality oversight. Analysts did not record certain results assessed as too numerous to count and selectively documented results, while cracked and desiccated plates were reported as within limits or as 0 CFU. FDA also observed a colony on a plate recorded as 0 CFU. The procedure did not require secondary verification of initial zero counts, and compromised plates were discarded without secondary review. FDA found that aberrant media conditions were not thoroughly investigated; the firm’s retrospective conclusions relied on interviews and records it acknowledged were unreliable, without photographic evidence of plate conditions. FDA considered the response inadequate because it did not assess effects on certificates of analysis or customers, verify historical data completeness, or commit to discontinuing damaged plates. FDA further stated that the quality unit lacked adequate authority, oversight, and control over laboratory operations and requested independent assessments, CAPA, stronger investigation systems, sample custody controls, photographic documentation, and quality-unit remediation.

FDA Warning Letter: Pine Pharmaceuticals cited for aseptic control, investigation, and validation deficiencies

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FDA inspected Pine Pharmaceuticals’ outsourcing facility from November 4–14, 2025, and found evidence of insanitary conditions and CGMP violations in production of drugs intended to be sterile. Operators did not sanitize materials, equipment, hands, or sleeves appropriately when moving from the ISO 7 area into the ISO 5 critical area. FDA also found that routine environmental monitoring did not cover manually handled, high-touch staging trays with a difficult-to-clean design. The letter cites inadequate investigations, deficient aseptic and sterilization process procedures and validation, inadequate personnel qualification, and deficient yield and reject-rate controls. FDA said particulate defects could bypass investigation triggers, while undefined “cosmetic” defects could be returned to batches. Responses were considered unsupported or deficient, including failure to establish root causes for particulates and recurring closure or inspection defects, reliance on reinspection and retrospective risk assessments, and incomplete CAPAs. FDA also found inadequate change control and requalification of visual inspectors, incomplete reject-rate corrections, and undefined, operator-dependent mixing parameters without a detailed validation plan.

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.

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.

FDA Warning Letter: Jabil sterile manufacturing deficiencies involving fungal contamination and quality oversight

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FDA’s February 23 to March 6, 2026, inspection of Pharmaceutics International, Inc., a Jabil company and contract manufacturer of sterile injectables, identified significant finished-pharmaceutical CGMP violations. FDA found inadequate investigations of a sterility failure involving Ustilago spermophora and recurring fungal recoveries in Grade A filling areas, including insufficient root-cause analysis, trend evaluation, and CAPA. The quality unit did not ensure complete documentation of aseptic interventions; one batch record documented 12 interventions although records indicated approximately 200 occurred. FDA also cited inadequate disinfectant efficacy studies and failure to perform process validation after adding a production step. Airflow visualization studies were deficient or omitted following RABS modifications, and some interventions lacked adequate smoke visualization. Environmental monitoring used insufficient sampling techniques and locations. Classified areas also had peeling paint and plastic debris. FDA considered the company’s responses inadequate because they did not sufficiently address contamination sources, systemic investigation weaknesses, quality oversight, or sustainable remediation.

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.

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.