Glossary
Quarantine
The status of materials or products held physically or by another effective means apart, pending a decision on release, rejection, or reprocessing.
Source · WHO Quality Assurance of Medicines Terminology Database, Quarantine
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
Your firm was both unable to provide any written documentation of what products were held in or released from quarantine, and unable to provide records explaining how suspect product was quarantined.
FDA · FDA Warning Letter · 2023-06-27 -
For example, your firm utilized software (i.e., (b)(4) ) for the retention of data, including your drug product formulations and the quarantine and…
FDA · FDA Warning Letter · 2022-05-17 -
Failure to clearly identify an HCT/P that is in quarantine pending completion of a donor-eligibility determination and failure to ship HCT/Ps with the required accompanying records for which the donor eligibility determination has not been completed [21 CFR 1271.60(b) and (c)] .
FDA · FDA Warning Letter · 2024-05-21
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database, QuarantineGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
Browse the whole glossary