# FDA 483 - Xellia Pharmaceuticals USA LLC - September 29, 2023

Source: https://www.globalkeysolutions.net/records/483/xellia-pharmaceuticals-usa-llc/93d44f5f-72c1-46b2-a9d2-b59938687b28

> FDA 483 for Xellia Pharmaceuticals USA LLC on September 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xellia Pharmaceuticals USA LLC
- Inspection Date: 2023-09-29
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Xellia Pharmaceuticals USA LLC in Bedford, OH, a manufacturer of sterile drug products, received a Form 483 with two observations. The inspection revealed significant deficiencies in aseptic process validation, including unrepresentative media fills and inadequate smoke studies for Vancomycin production. Additionally, the firm failed to conduct thorough investigations into unexplained discrepancies, such as the source of a metal shard found in a Vancomycin batch.

## Related Documents

- [483 - 2022-02-07](https://www.globalkeysolutions.net/records/483/xellia-pharmaceuticals-usa-llc/2f5255cd-c4f9-46a6-aad5-f2c327bae925)
- [483 - 2022-12-15](https://www.globalkeysolutions.net/records/483/xellia-pharmaceuticals-usa-llc/fb9c3922-3ea2-46e3-b56c-84b4eb9e352d)

## Related Officers

- [Nicholas J. Presto](https://www.globalkeysolutions.net/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)
- [Investigator](https://www.globalkeysolutions.net/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)

Company: https://www.globalkeysolutions.net/companies/xellia-pharmaceuticals-usa-llc/a3a2eda2-040c-4cb8-8df0-2dd3fb12332f

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22