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Out-of-Specification Investigations – Lessons Learned, or Not?
The FDA Guidance for Industry, Investigating Out‑of-Specification (OOS) Test Results for Pharmaceutical Production, was published in October 2006 (here). The pharmaceutical industry has had about 14 years to learn how to comply to this guidance. A quick survey of recent Form 483s and Warning Letters would indicate that there is still much to be learned […]