# Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigating-out-of-specification-oos-test-results-for-pharmaceutical-production-level-2-revision-guidance-for-industry/1e06deea-ceb4-4e41-b2d2-1b4611f8ccdd

> FDA guidance document: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision:  Guidance for Industry. Issue date: May 16, 2022. Get complete insights and analysis.

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## Details

- Title: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2022-05-16
- Last Changed: 2024-08-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1998-D-0019">FDA-1998-D-0019</a>

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