# FDA 483 - Amnio Technology, LLC - August 29, 2022

Source: https://www.globalkeysolutions.net/records/483/amnio-technology-llc/bf61b232-14c6-4af9-a13b-bf8e3602c5e2

> FDA 483 for Amnio Technology, LLC on August 29, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amnio Technology, LLC
- Inspection Date: 2022-08-29
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Amnio Technology, LLC in Phoenix, AZ, was cited for significant deficiencies in its manufacturing processes and quality control systems for injectable amniotic products. Observations included a lack of validated production processes, inadequate stability data, and deficient complaint handling procedures, alongside a failure to report a serious adverse event to the FDA.

## Related Documents

- [WARNING_LETTER - 2022-08-29](https://www.globalkeysolutions.net/records/warning_letter/amnio-technology-llc/00485e25-c77f-4c83-94f5-086ed0f4deb0)

## Related Officers

- [Garrad R. Poole](https://www.globalkeysolutions.net/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)
- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.globalkeysolutions.net/companies/amnio-technology-llc/a0c724bf-f301-4027-a17e-01bdc4e0dc3a

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6