# FDA 483 - Resilience US, Inc. - August 09, 2019

Source: https://www.globalkeysolutions.net/records/483/resilience-us-inc/dd56e69e-9d18-4392-a7f6-6e6f8ffd3b16

> FDA 483 for Resilience US, Inc. on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resilience US, Inc.
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Amylin Ohio LLC, a sterile drug manufacturer in West Chester, OH, was cited for three observations during an FDA inspection. The firm failed to adequately control and document rejected in-process materials, lacked proper disposition records for scrapped finished goods, and did not thoroughly investigate unexplained discrepancies and batch failures during packaging validation. These issues indicate deficiencies in material control, record-keeping, and quality system investigations.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)
- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)
- [Drug Specialist](https://www.globalkeysolutions.net/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

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

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