# FDA 483 - AMPLIFY BIO - August 05, 2021

Source: https://www.globalkeysolutions.net/records/483/amplify-bio/eccfceaf-f159-48f4-b15a-8e3f6b8caedc

> FDA 483 for AMPLIFY BIO on August 05, 2021. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AMPLIFY BIO
- Inspection Date: 2021-08-05
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: AMPLIFY BIO, a non-clinical laboratory in West Jefferson, OH, received a Form 483 with three observations. The inspection revealed that nonclinical studies were not conducted according to protocol, specifically concerning animal age. Additionally, the firm failed to properly identify specimens with collection dates and lacked established procedures for handling test and control articles to prevent contamination.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.globalkeysolutions.net/companies/amplify-bio/fba30015-5518-4683-83bf-1482a40a061d

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