# FDA 483 - Resilience US, Inc. - May 25, 2022

Source: https://www.keypedia.com/records/483/resilience-us-inc/94636e51-32ab-43c5-a472-c9dfcb50380a

> FDA 483 for Resilience US, Inc. on May 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resilience US, Inc.
- Inspection Date: 2022-05-25
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Amylin Ohio LLC, a sterile drug manufacturer in West Chester, OH, was cited for multiple significant deficiencies related to its Bydureon BCise injectable suspension product. Observations included issues with unqualified equipment, inadequate personnel training, insufficient investigation into batch failures, failure to reject non-conforming products, and non-adherence to written procedures. These findings indicate a lack of robust quality control and manufacturing process oversight.

## Related Documents

- [483 - 2009-12-23](https://www.keypedia.com/records/483/resilience-us-inc/692c58e3-a3a2-4a48-9047-947fe1547fd4)
- [483 - 2019-08-09](https://www.keypedia.com/records/483/resilience-us-inc/dd56e69e-9d18-4392-a7f6-6e6f8ffd3b16)
- [483 - 2025-01-21](https://www.keypedia.com/records/483/resilience-us-inc/e0694569-a72d-4825-9058-6c93c6f430ec)

## Related Officers

- [Courtney E. Hillier](https://www.keypedia.com/people/courtney-e-hillier/4bb6ba54-896a-4296-a4ea-81d8801fdc2f)
- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

Company: https://www.keypedia.com/companies/resilience-us-inc/864cabb1-d73c-4706-8d04-3e5c2375f44e

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