483
Emergent Biodefense Operations Lansing LLCEmergent Biodefense Operations Lansing LLC – FDA 483, Sep 29, 2021
Record Details
An FDA inspection of Emergent BioDefense Operations Lansing LLC in Lansing, MI, revealed that the firm's reserve drug product samples were not representative of each lot or batch. This issue stemmed from an inadequate sample collection plan and a deficient standard operating procedure (SOP) for retention sampling. The firm failed to collect samples throughout the entire production lot for products like BioThrax® and AV7909.
- Inspection date
- September 29, 2021
- Product type
- biologics
View Company Profile
ID · 897aede3-ab80-4bab-86b4-583db5c1bc99
Other documents for Emergent Biodefense Operations Lansing LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.