Glossary
Reprocessing
Returning an intermediate or API that does not conform to standards or specifications to a defined process step and repeating the established process.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
FDA · FDA 483 · 2019-09-30 -
Reprocessing procedures lack the steps to be taken to ensure that reprocessed batches will conform with all established standards, specifications, and characteristics.
FDA · FDA 483 · 2025-09-04 -
Reprocessing was performed without the review of the quality control unit.
FDA · FDA 483 · 2024-01-17
