# FDA 483 - Cardinal Health 414 LLC - November 08, 2018

Source: https://www.globalkeysolutions.net/records/483/cardinal-health-414-llc/ace5d5e1-10dc-4b55-aaaf-4ccb2ee28109

> FDA 483 for Cardinal Health 414 LLC on November 08, 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: 2018-11-08
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cardinal Health 414 LLC in Tampa, FL, a PET Drug Manufacturer, was cited for inadequate facilities to prevent contamination during an FDA inspection. The firm failed to evaluate and mitigate the risk of cross-contamination from ongoing adjacent construction activities. Additionally, there was incomplete documentation for HVAC maintenance, which contributed to fungal contamination in ISO 5 areas where sterile injectable PET drug products are manufactured.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/binh-t-nguyen/14ca5620-1f92-4f5d-8663-3b63814aca26)
- [Ileana Barreto-Petit](https://www.globalkeysolutions.net/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

Company: https://www.globalkeysolutions.net/companies/cardinal-health-414-llc/ac29a561-71ff-41a6-86b1-cfd314da6b33

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6