# FDA 483 - Cardinal Health 414 LLC - August 28, 2025

Source: https://www.keypedia.com/records/483/cardinal-health-414-llc/71fb771a-9bda-459f-9de1-8eb2d752de64

> FDA 483 for Cardinal Health 414 LLC on August 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 414 LLC
- Inspection Date: 2025-08-28
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Cardinal Health 414 LLC, a PET drug manufacturer in Van Nuys, CA, was cited for failing to approve processes and procedures before implementation. The inspection revealed deficiencies in media fill simulations, which did not adequately qualify production operators or represent actual manufacturing conditions. Additionally, the visual inspection test kit used for operator qualification was deemed inadequate, indicating a lack of robust quality control over critical manufacturing processes.

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Company: https://www.keypedia.com/companies/cardinal-health-414-llc/03fda551-7fa3-4ca0-aac4-dd84cbfa8223

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b