Glossary
Visual Inspection
Examining filled containers one by one to detect foreign matter or defects.
Source · EudraLex Volume 4, Annex 1 (2022), §§8.30–8.32
Details
This does not end at sorting accept from reject: defect types are classified so that the rate per batch can be trended. Annex 1 requires a defect library of known defects to be built and used in training, inspectors to be qualified at least annually, and automated inspection to be validated to detect as well as or better than manual inspection. The corpus cites an inspection programme inadequate to assure sterile injectables, bulk vials not visually examined, and critical defects found at inspection left uninvestigated.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, there was no procedure for 100% visual inspection of the final drug product to ensure that it is essentially free from visible particulates, which is necessary to ensure quality and purity prior to intravascular administration.
FDA · FDA Warning Letter · 2024-08-27 -
Your visual inspection (VI) process and VI training program remain deficient.
FDA · FDA Warning Letter · 2025-11-25 -
You failed to conduct adequate investigations into endotoxin testing and your 100% automated visual inspection system.
FDA · FDA Warning Letter · 2023-08-01
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EudraLex Volume 4, Annex 1 (2022), §§8.30–8.32GRM Regulatory Glossary
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