483
American Injectables IncAmerican Injectables Inc – FDA 483, Nov 25, 2024
Record Details
An FDA inspection of American Injectables Inc in Brooksville, FL, revealed deficiencies in the firm's aseptic processing areas. Specifically, the company lacked documented empirical data to support the selected active viable air sampling locations, indicating a weakness in their environmental monitoring system.
View Company Profile
ID · fd87ed4a-1736-4626-9889-8364a9994e23
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.