Glossary
Cleanroom
A room designed and operated to control airborne particle concentration and to reduce the introduction, generation, and retention of particles and microorganisms.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Regarding the (b)(4) totes used to transfer materials from non-classified areas into the ISO (b)(4) cleanroom suite, your response referenced an existing CAPA for CV and you also noted that updated studies were initiated.
FDA · FDA Warning Letter · 2025-11-25 -
Your firm did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 hood.
FDA · FDA Warning Letter · 2023-08-08 -
Your responses to Observation 3B include a Maintenance report from July 29, 2022 – July 31, 2022, where multiple repairs and updates to the cleanroom and LFHs were documented.
FDA · FDA Warning Letter · 2023-05-30
