Glossary
Finished Product
A medicine that has completed all stages of production, including filling into the final container and packaging.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your program for the visual inspection of sterile injectable drug products does not provide adequate assurance that finished products…
FDA · FDA Warning Letter · 2023-08-01 -
Release of Batch with Incomplete Finished Product Testing Your firm failed to establish an adequate quality unit (QU) to oversee the manufacture of your drug products.
FDA · FDA Warning Letter · 2025-04-29 -
Without endotoxin controls (such as endotoxin data on CoAs for bulk drug substances and other components, finished product endotoxin testing, etc.), there are no assurances that intrathecal drug products are safe for their intended use.
FDA · FDA Warning Letter · 2023-06-13
