Afton Scientific, LLC
FDA inspection history in Charlottesville, Virginia, 2019 to 2024
- 5
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483; 2023: two Form 483s; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–24Five Form 483s, at Charlottesville, Virginia.
- 2023The longest 483 on file: 8 observations over 8 pages at Charlottesville, Virginia.
Cited most
Across all Afton Scientific observations on file
- 21 CFR 211.142(b)Warehousing procedures2
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.67Equipment cleaning and maintenance2
The complete Afton Scientific file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Charlottesville, Virginia
Five Form 483s · 2019 to 2024 · 24 observations
Latest: Form 483, May 8, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-08 | 483 Form 483 | Charlottesville, Virginia | 4 | $99 |
| 2023-10-06 | 483 Form 483 | Charlottesville, Virginia | 8 | $99 |
| 2023-04-06 | 483 Form 483 | Charlottesville, Virginia | 3 | $99 |
| 2021-10-22 | 483 Form 483 | Charlottesville, Virginia | 2 | $99 |
| 2019-06-14 | 483 Form 483 | Charlottesville, Virginia | 7 | $99 |
Investigators on these documents
Amy N. Chen (1)Brentley Collins (1)Cody D. Rickman (1)Gayle S. Lawson (1)Jonah S. Ufferfilge (1)Kristina L. Conroy (1)Laurel A. Beer (1)Saleem A. Akhtar (1)Thomas R. Withers (1)William Leonard (1)
FEI number 1000123236 · most recent document May 8, 2024
About Afton Scientific, LLC
How many FDA Form 483s has Afton Scientific, LLC received?
FDA Intel has 5 Form 483s on file for Afton Scientific, LLC; the most recent is dated May 8, 2024.
When was Afton Scientific, LLC last inspected by FDA?
The most recent FDA inspection document on file for Afton Scientific, LLC is a Form 483 dated May 8, 2024, for the site in Charlottesville, Virginia.
What did FDA cite at Afton Scientific, LLC?
The regulations cited most in the observations on file for Afton Scientific, LLC are 21 CFR 211.142(b) (Warehousing procedures), 2 times; 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times.