Contamination Control

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: Signature Formulations cited for systemic cross-contamination and quality system failures

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FDA states that laboratory testing of (b)(4) lots of contract-manufactured (b)(4) drug products found contamination in every lot tested, including undeclared (b)(4) above the stated limit of quantitation and, in many cases, at far higher levels. The agency linked the findings to manufacturing (b)(4) products in the same environment on shared equipment. FDA said residues from the active ingredients would not be adequately removed from shared surfaces and equipment under standard cleaning conditions and that the firm had not established appropriate design and control procedures to prevent hazardous cross-contamination. Because contamination was confirmed across all randomly sampled lots, FDA characterized the problem as systemic, nonuniformly distributed, and not resolvable through retrospective testing. FDA also cited insanitary conditions, ineffective management oversight, and a quality unit lacking sufficient authority or implementation of its responsibilities. FDA recommended recall of all distributed drug products; the firm verbally committed to halt manufacturing and distribution and recall all (b)(4) drug products. FDA also noted a 2025 recall for contamination.

EU GMP Non-Compliance: Glukem Biocare Private Limited – contamination risk in cleaned fluid-bed coating equipment

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After the inspection ending 15 September 2026, the Malta Medicines Authority considered the site non-compliant for non-sterile pellet manufacture and quality-control testing. A critical deficiency concerned contamination risk in cleaned fluid-bed coating equipment: liquid pooling and residue were observed in an inlet-air plenum. The authority linked this to a design that prevented gravity drainage and an inadequate cleaning procedure. There was also no real-time differential-pressure monitoring before and after the supply-air HEPA filter to detect integrity failure. Eleven major findings covered production records, process and cleaning validation, differential-pressure excursions, warehouse, sampling and dispensing controls, vendor qualification, starting-material identification, excipient risk assessments, OOS handling, equipment qualification and pest control. The authority stated that no site-manufactured batches should be released to EEA markets while the statement remains in place, unless superseded by an EU GMP certificate. Under the revocation heading, it recommended that member states consider not initiating or authorising new marketing authorisations listing the site; it did not state that existing authorisations were revoked. The authority said products should not be present in EEA markets and did not propose a teleconference.

Par Health Recalls 22 Argatroban Injection Lots for Particulate Matter

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Par Health USA announced a nationwide, hospital/user-level recall of 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) after particulate matter was detected in certain lots. Identified materials included cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. The affected lots were distributed to wholesalers and hospitals between December 30, 2024, and May 5, 2026. Par Health stated that administration of affected product could cause life-threatening vascular and inflammatory consequences. No related adverse events had been reported. Wholesalers and hospital pharmacies were instructed to discontinue use and distribution immediately and return existing inventory.

FDA Warning Letter: Hanlim Pharm cited for sterile manufacturing and quality system deficiencies

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FDA cited significant CGMP violations following an April 2026 inspection of Hanlim Pharm’s drug manufacturing facility. Inspectors observed poor aseptic practices, including operators obstructing first air, working directly over exposed components, and wearing a visibly stained gown. Dynamic smoke studies did not demonstrate adequate unidirectional airflow protection and indicated possible entrainment of lower-quality air into the ISO 5 processing line. FDA also found that critical container-closure contact surfaces were wiped with sporicidal disinfectants rather than sterilized. Environmental monitoring locations and frequencies were not adequately justified or sufficient to detect contamination risks near containers, closures, and barriers facing ISO 5 areas. The visual inspection program lacked routine defect categorization and appropriate acceptance criteria despite significant defect rates. FDA further stated that the quality unit lacked adequate authority and oversight, citing failures involving the stability program and contemporaneous documentation of environmental and personnel monitoring data. FDA considered the company’s responses inadequate and noted similar violations in a previous warning letter.

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.

Par Health Recalls Two Brevital Sodium Lots for Cellulose Particulate Matter

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Par Health announced a voluntary nationwide recall to the hospital level of two lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) after particulate matter identified as cellulose was found. The affected lots are 86930, expiring February 2028, and 88623, expiring April 2028; they were distributed to wholesalers nationwide between July 8, 2025, and May 11, 2026. Par said use could cause life-threatening vascular consequences, although it had received no related adverse-event reports. Wholesalers and hospital pharmacies were instructed to stop use and distribution immediately, notify downstream accounts, and return inventory through Inmar. FDA posted the company announcement and noted that posting does not constitute endorsement.

EU GMP Non-Compliance: Ocb Pharmaceutical S.R.L. – relabelling and distribution obscured bismuth subsalicylate supply-chain traceability

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Following an inspection ending 27 August 2026, the Spanish NCA identified nine deficiencies: one critical and eight major. The critical deficiency concerned repackaging and relabelling bismuth subsalicylate from a Chinese manufacturer operating outside the EU GMP framework. OCB assigned new batch numbers, copied supplier results into certificates of analysis, replaced or removed original labels, and distributed material without adequately preserving manufacturer identity and supply-chain traceability. Major deficiencies affected investigations, CAPA, risk management, data integrity, personnel qualification, materials traceability, contamination controls, cleaning, facilities, documentation and quality oversight. The NCA temporarily suspended all API and intermediate manufacturing at Canovelles and suspended distribution and sale of material manufactured, repackaged or relabelled there, pending correction and verification through reinspection. No recall was considered necessary because no specific defects in marketed batches were detected. The NCA said suspension of the site’s bismuth subnitrate CEP should be considered. It also withdrew the current GMP certificate and recommended justified testing by customers, alternative qualified sources, and exclusion from new or ongoing applications while the statement remains in force.

FDA Terminates Haleon Robitussin Recall for Microbial Contamination

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FDA posted Haleon’s January 24, 2024 announcement of a voluntary consumer-level recall of eight lots of Robitussin Honey CF Max Day Adult and Nighttime Adult cough syrups because of microbial contamination. Haleon stated that affected products could potentially cause severe or life-threatening infections in immunocompromised individuals, while infections requiring medical intervention could not be completely ruled out in other consumers. No related adverse events had been reported at the time of the announcement. Haleon notified distributors and customers, provided return instructions, and advised consumers to stop use immediately. The FDA page now states that the recall has been completed and FDA has terminated it.

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.