Environmental Monitoring

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.

FDA Warning Letter: Microbiological OOS Investigations and Quality Unit Oversight at Silgan

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FDA inspected Silgan Unicep Packaging’s Spokane, Washington, drug manufacturing facility from March 26 to April 2, 2026, and reported significant CGMP violations involving non-sterile OTC products. FDA found that the firm inadequately investigated OOS microbiological results for components. Individual yeast and mold failures were invalidated by averaging sample results to obtain passing outcomes, and the sampling plan was revised to permit averaging, which FDA said was inconsistent with USP and could obscure non-uniform contamination. Affected component lots were released and used in distributed product. FDA also found the investigation associated with a Class I recall for potential fungal contamination inadequate: a bioburden-reduction corrective action was ineffective, related change control lacked appropriate validation and evaluation, the manufacturing line lacked cleaning procedures and cleaning validation, and environmental monitoring omitted yeast and mold testing. Separately, FDA said the quality unit failed to ensure supplier test reliability, follow the written stability program, and complete annual product reviews. FDA deemed the responses inadequate because they lacked sufficient scope, supporting evidence, effectiveness verification, product-risk measures, and remediation of systemic quality oversight failures.

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 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: 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.