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

Source: https://www.keypedia.com/records/483/amnio-technology-llc/1abef5fe-77b5-4a1e-8a41-4b10a6bfa042

> 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: Los Angeles District Office
- Summary: A recent FDA inspection of Amnio Technology, LLC, conducted from August 15 to August 29, 2022, uncovered significant compliance deficiencies. Operating as a biological drug and human cell, tissue, and cellular and tissue-based product (HCT/P) distributor, the company received several observations under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Key issues included the failure to establish adequate written procedures for production and process controls, specifically concerning the unvalidated manufacturing processes for their injectable amniotic products: PalinGen Flow, PalinGen InnovoFlo, and ProMatrX, which were nevertheless distributed commercially. Additionally, the firm failed to report a serious adverse event involving patient hospitalization linked to PalinGen Flow. The inspection also identified a lack of a written program to assess drug product stability, resulting in unsupported two-year expiry dates for their products. Finally, the company's procedures for handling complaints were found deficient, particularly in documenting complaint receipt methods. Amnio Technology, LLC, is expected to implement comprehensive corrective actions to address these observations, ensuring validated processes, timely adverse event reporting, scientifically supported product stability, and robust complaint handling to achieve regulatory compliance.

## Related Documents

- [483 - 2022-08-29](https://www.keypedia.com/records/483/amnio-technology-llc/bf61b232-14c6-4af9-a13b-bf8e3602c5e2)
- [WARNING_LETTER - 2022-08-29](https://www.keypedia.com/records/warning_letter/amnio-technology-llc/00485e25-c77f-4c83-94f5-086ed0f4deb0)

## Related Officers

- [Gregory Stone](https://www.keypedia.com/people/gregory-stone/6fc15653-2d1b-46d6-89dd-655a40ea72de)
- [Professor of Medicine](https://www.keypedia.com/people/lawrence-r-deyton/92881ee2-c62d-4faf-b619-4900022cc779)
- [Travis S Bradley, Investigator](https://www.keypedia.com/people/travis-s-bradley-investigator/ee1a3caf-b215-438a-8ec0-403223a9450f)
- [Garrad R. Poole](https://www.keypedia.com/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b