# FDA 483 - American Injectables Inc - November 25, 2024

Source: https://www.globalkeysolutions.net/records/483/american-injectables-inc/fd87ed4a-1736-4626-9889-8364a9994e23

> FDA 483 for American Injectables Inc on November 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Injectables Inc
- Inspection Date: 2024-11-25
- Product Type: drugs
- Office Name: Florida District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.globalkeysolutions.net/companies/american-injectables-inc/bb44b702-9cd3-4182-85ea-233d930c960a

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9