# FDA 483 - Afton Scientific, LLC - June 14, 2019

Source: https://www.keypedia.com/records/483/afton-scientific-llc/68d0b06f-1120-4a5e-ae92-257eb6a89b2a

> FDA 483 for Afton Scientific, LLC on June 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Afton Scientific, LLC
- Inspection Date: 2019-06-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Afton Scientific LLC, a drug manufacturer in Charlottesville, VA, was inspected by the FDA and cited for multiple deficiencies. The inspection revealed significant issues in aseptic processing validation, laboratory controls, and drug product storage conditions. Additionally, the firm failed to adequately manage electronic records, prevent contamination in sterile areas, and thoroughly investigate product complaints and environmental monitoring discrepancies.

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## Related Officers

- [William Leonard](https://www.keypedia.com/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)
- [PreApproval Manager](https://www.keypedia.com/people/gayle-s-lawson/cd8061de-f089-408c-bbfc-c7c7a5635dd7)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e