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483
•American Injectables Inc•November 25, 2024

FDA 483 - American Injectables Inc - November 25, 2024

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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.

Company
American Injectables Inc
Inspection Date
November 25, 2024
Product Type
Drugs
Office
Florida District Office
Person
  • Marian E. Ramirez (investigator)
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ID · fd87ed4a-1736-4626-9889-8364a9994e23

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