US FDA
Carolina Infusion LLC
2026-09-22
The Cleanroom areas contain dust-collecting overhangs without adequate and frequent cleaning.
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US FDA Environmental monitoring findings
by this agency in this category 129 findings drawn from 106 published documents. The most recent cases are below; the full set is in search.
See all US FDA Environmental monitoring findingsCompanies with the most findings
Recent findings
US FDA
Carolina Infusion LLC
2026-09-22
Lack of and Inadequate routine environmental monitoring in the ISO 5 area and classified areas.
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US FDA
Biotechnologines farmacijos centras Biotechpharma UAB
2026-07-13
Your environmental monitoring program is deficient.
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US FDA
Jubilant HollisterStier General Partnership
2026-06-23
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm lacked adequate systems to ensure sufficient and timely investigations. A. Your firm failed to investigate multiple action-level environmental monitoring excursions that occurred between January and June 2025 in the ISO 5 and 7 areas. Your…
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US FDA
Central Alabama Veterans Health Care System
2026-05-27
Inadequate routine environmental monitoring in the ISO 5 area.
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US FDA
ProRx LLC
2026-05-12
You did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 laminar airflow workstation (LAFW). Specifically, an operator removed the outer packaging of stoppers in the ISO 7 area and the inner bag was then transferred from the ISO 7 area into the ISO 5 LAFW without surface disinfection. The inner bag of stoppers could be held for up to (b)(4) within the ISO 7 area before being transferred into the ISO 5 LAFW.
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These findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-10-20, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
