Glossary
Bulk Product
Product that has completed every processing stage except final packaging.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The company manufactures exclusively non-sterile bulk products.
EMA · EU GMP NCR (EudraGMDP) · 2025-10-23 -
You have not established written procedures that describe the manufacture of ActivePro™, which was described to FDA investigators during the inspection as being manufactured from ActiveShot™ and ActiveFlow™ final bulk products.
FDA · FDA Warning Letter · 2022-06-28 -
The following OOSs occurred during the annual stability testing ofbulk products.
FDA · FDA 483 · 2024-01-17
