# FDA 483 - Xellia Pharmaceuticals USA LLC - February 07, 2022

Source: https://www.keypedia.com/records/483/xellia-pharmaceuticals-usa-llc/2f5255cd-c4f9-46a6-aad5-f2c327bae925

> FDA 483 for Xellia Pharmaceuticals USA LLC on February 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xellia Pharmaceuticals USA LLC
- Inspection Date: 2022-02-07
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Xellia Pharmaceuticals USA LLC in Bedford, OH, a manufacturer of sterile drug products, revealed a significant lapse in quality control unit procedures. The firm failed to submit a field alert report within the required three-day timeframe following notification of an out-of-specification stability result for a distributed batch of Vancomycin Hydrochloride for Injection USP. This delay indicates a failure to adhere to established internal procedures for critical product quality issues.

## Related Documents

- [483 - 2022-12-15](https://www.keypedia.com/records/483/xellia-pharmaceuticals-usa-llc/fb9c3922-3ea2-46e3-b56c-84b4eb9e352d)
- [483 - 2023-09-29](https://www.keypedia.com/records/483/xellia-pharmaceuticals-usa-llc/93d44f5f-72c1-46b2-a9d2-b59938687b28)

## Related Officers

- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)
- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

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

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