# FDA 483 - Afton Scientific, LLC - April 06, 2023

Source: https://www.keypedia.com/records/483/afton-scientific-llc/e2735a1f-25f4-4d1a-ba1b-68e41bc459a2

> FDA 483 for Afton Scientific, LLC on April 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Afton Scientific, LLC
- Inspection Date: 2023-04-06
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Afton Scientific, LLC in Charlottesville, VA, a sterile manufacturer, revealed three significant observations. The firm was cited for using equipment not appropriately designed for cleaning and maintenance, specifically rusted tongs in an aseptic processing area. Additionally, the inspection found a lack of established written procedures for equipment cleaning and maintenance, with cleaning efficacy studies failing to validate methods for an active pharmaceutical ingredient. Finally, the firm failed to follow its own written procedures for testing and approving drug product containers, specifically neglecting bioburden and endotoxin testing for vials since 2019.

## Related Documents

- [483 - 2019-06-14](https://www.keypedia.com/records/483/afton-scientific-llc/68d0b06f-1120-4a5e-ae92-257eb6a89b2a)
- [483 - 2021-10-22](https://www.keypedia.com/records/483/afton-scientific-llc/1554fd07-8569-43b5-a5c7-ab5d9a08434b)
- [483 - 2023-10-06](https://www.keypedia.com/records/483/afton-scientific-llc/8416fb68-9dc8-43eb-9649-fa45aab90390)

## Related Officers

- [Regional Manager](https://www.keypedia.com/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Investigator](https://www.keypedia.com/people/amy-n-chen/c3515e0e-dbb9-4540-bd2b-82c06d00dd42)

Company: https://www.keypedia.com/companies/afton-scientific-llc/e5ec92fc-2eb5-4366-8d78-fd597c977fe8

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64