# FDA 483 - KEDRION S. p. A. - September 16, 2016

Source: https://www.keypedia.com/records/483/kedrion-s-p-a/9211c8d4-ad2c-4c35-a29f-02b7e007816a

> FDA 483 for KEDRION S. p. A. on September 16, 2016. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KEDRION S. p. A.
- Inspection Date: 2016-09-16
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: An FDA inspection conducted at Kedrion S. p. A.'s bio-pharmaceutical manufacturing facility in Bolognana, Italy, from September 8-16, 2016, revealed multiple deviations from regulatory standards. The primary concern was the company's inadequate investigation and corrective actions following persistent issues with high reject rates for filaments and aggregates in Kedbumin drug product batches. The firm failed to thoroughly evaluate manufacturing process times, justify exclusion of process anomalies, or validate critical process steps, which contributed to these quality defects. Further issues included the absence of identity testing for final product containers after labeling, and the non-representative nature of retain and stability samples, as defective vials were removed before storage. Significant deficiencies were also noted in quality assurance processes, specifically with visual inspection and labeling line clearances lacking proper verification and documentation. The facility itself presented challenges, with inadequate space leading to improper storage of un-cleaned equipment, materials, and quarantined batches in corridors. Compounding these findings, several critical observations from a previous 2014 inspection, concerning the testing and toxicological evaluation of extractables and leachables from product contact surfaces, remained unaddressed. Kedrion S. p. A. is required to implement robust corrective and preventive actions to ensure compliance with Good Manufacturing Practices.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)
- [Plant Manager](https://www.keypedia.com/people/raniero-dascoli/c35839b2-3d1d-4269-8830-da94cc57158f)

Company: https://www.keypedia.com/companies/kedrion-s-p-a/2a4bbd5a-ede3-4010-b594-3fb5b272e4b9

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d