# FDA 483 - Cardinal Health 414, LLC - August 03, 2018

Source: https://www.globalkeysolutions.net/records/483/cardinal-health-414-llc/ba86b0a7-eab9-453f-9a2f-3b76161db6c8

> FDA 483 for Cardinal Health 414, LLC on August 03, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 414, LLC
- Inspection Date: 2018-08-03
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Cardinal Health 414, LLC, a PET drug manufacturer in New Orleans, LA, received a Form 483 for significant deficiencies in equipment procedures, environmental monitoring, and aseptic processing. The inspection revealed inadequate controls for ensuring equipment suitability and sterility, as well as facility conditions and personnel practices that could lead to product contamination. These issues pose a risk to the quality and purity of PET drugs manufactured at the facility.

## Related Officers

- [CO CDER OMQ](https://www.globalkeysolutions.net/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.globalkeysolutions.net/companies/cardinal-health-414-llc/d22415fc-cacf-46cd-9af9-fe495146ea6f

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea