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: Component Testing and Quality Unit Deficiencies at Zhejiang Gaorong Cosmetic

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FDA identified significant CGMP violations during a review of records submitted by Zhejiang Gaorong Cosmetic Co., Ltd., an OTC drug manufacturer. The firm did not demonstrate adequate testing of every shipment of each incoming component lot before use. Documentation lacked adequate identity and impurities testing for redacted components described as being at risk or high risk for contamination. The firm also accepted active pharmaceutical ingredients based on supplier certificates of analysis without establishing the reliability of supplier testing at appropriate intervals. FDA stated that this left the firm without scientific evidence that components or drug products met appropriate specifications before use. FDA also found that the quality unit did not effectively oversee drug manufacturing operations, including ensuring complete batch-production records and adequate stability data supporting product expiry. FDA requested component testing and supplier-reliability plans, contract laboratory oversight, risk assessment and testing for implicated materials and products, supplier and material-system review, and comprehensive quality-unit remediation.

FDA Warning Letter: SnugZ USA cited for OOS, laboratory, supplier, and quality unit deficiencies

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FDA states that its April 27 to May 1, 2026 inspection of SnugZ USA’s OTC drug manufacturing facility identified significant CGMP violations. The firm routinely failed to investigate out-of-specification chemical and microbiological results, instead retesting or preparing new samples until passing results were obtained and using those results for product release. Complaint investigations lacked adequate root cause determinations and CAPA. Laboratory procedures permitted repeated testing without investigations and allowed analysts discretion regarding unidentified chromatographic peaks. FDA also found unsupported tiered microbiological testing, with failing results invalidated in favor of passing results from a second instrument. Incoming components were not adequately identity-tested or representatively sampled, and supplier certificates of analysis were accepted without establishing their reliability through confirmatory testing. FDA further states that the quality unit did not adequately oversee manufacturing, testing, records, investigations, release decisions, cleaning validation, or product quality reviews. Similar investigation and laboratory-control deficiencies had been observed previously, and FDA considered the firm’s remediation responses insufficiently detailed and sustainable.

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: Sterility, Component Testing, and Quality Unit Deficiencies at Jiangmen Shuizirun

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FDA states that its November 3–7, 2025, inspection of Jiangmen Shuizirun Sanitary Articles found significant CGMP violations in OTC drug manufacturing. Several products were labeled “sterile,” although they were not sterilized, the certificates of analysis did not claim sterility, and the firm did not perform release sterility testing. One released batch had a reported aerobic microbial count, which FDA said was unacceptable for a sterile-labeled drug. FDA also found inadequate identity and impurity testing for incoming components and purchased in-process materials, including high-risk ingredients, while supplier certificates were relied upon without establishing their reliability. The quality unit did not adequately oversee documentation, written production procedures, process and system validation, stability testing, or finished-product testing. FDA additionally noted that the same batch number was assigned to different products, and that neither the firm nor its U.S. Agent responded to FDA’s attempts to discuss recalling sterile-labeled products in U.S. distribution.

FDA cites CGMP violations at Jiangmen Shuizirun OTC drug facility

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FDA issued a warning letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. after a November 2025 inspection of its Chinese OTC drug manufacturing facility identified significant CGMP violations. FDA stated that products labeled “sterile” were not sterilized, lacked release sterility testing, and were assessed against microbial limits unacceptable for sterile drugs. The agency also cited inadequate identity and impurity testing of incoming components, reliance on supplier certificates without establishing reliability, and deficient quality-unit oversight of documentation, process validation, procedures, stability, and finished-product testing. FDA additionally identified non-unique batch numbering, recommended removal of within-expiry sterile-labeled products from the U.S. market, and noted that the firm’s drugs were placed on Import Alert 66-40.