# FDA 483 - KEDRION S. p. A. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/kedrion-s-p-a/d7e4943c-6b90-440c-8261-9ac0312903aa

> FDA 483 for KEDRION S. p. A. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KEDRION S. p. A.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: KEDRION S. p. A. in Bolognana, Italy, a bio-pharmaceutical drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately investigate and correct issues from a previous inspection, particularly concerning manufacturing process controls for Kedbumin drug product aggregates and filaments. Additionally, the inspection revealed inadequate space, issues with sample representativeness, and uncorrected observations related to extractables/leachables and toxicology studies.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

Company: https://www.globalkeysolutions.net/companies/kedrion-s-p-a/11d485aa-db7e-4992-8e94-3bf9f5470ceb

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd