Glossary
Laboratory Investigation
The investigation stage that first asks whether the laboratory is the cause when a test result falls outside specification.
Details
To attribute an out-of-specification result to laboratory error, the error has to be identified and evidenced; where it cannot be identified, the investigation must widen to production. The corpus cites retest results accepted as passing without the root cause being found, laboratory causes named but not supported by documentation, and intermediate failures where no investigation was performed at all. What is examined is who approved the decision to invalidate the original result and when, and where the retest sample came from.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Our inspection revealed serious deviations, including but not limited to, inadequate oversight of original CGMP documents, deficient controls over computerized systems, insufficient laboratory investigations, and aborted chromatographic sequences.
FDA · FDA Warning Letter · 2023-08-01 -
Laboratory investigations for OOS intermediate batches are not conducted.
FDA · FDA 483 · 2018-12-10 -
Laboratory investigations were not conducted timely based on an identifiable trend or thoroughly to determine the root cause.
FDA · FDA 483 · 2025-11-03
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
21 CFR 211.192 Production record review; FDA Guidance for Industry, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (Level 2 revision, 2022-05, Docket FDA-1998-D-0019)GRM Regulatory Glossary
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