Afton Scientific, LLC
Form 483 issued April 6, 2023 · Charlottesville, Virginia
- Inspection
- Mar 27 – Apr 6, 2023
- Investigators
- Amy N. Chen· Jonah S. Ufferfilge
- Observations
- 3
- Pages
- 4
- FEI number
- 1000123236
In short: On April 6, 2023, FDA issued a Form 483 with 3 observations to Afton Scientific, LLC in Charlottesville, Virginia (FEI 1000123236) after an inspection that ran Mar 27 – Apr 6, 2023. The investigators were Amy N. Chen and Jonah S. Ufferfilge. Most observations concern facilities & equipment and materials.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Written procedures are not followed for the testing and approval…
This inspection in context
Amy N. Chen
8 documents · 2022–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
The firmAfton Scientific, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Afton Scientific, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Afton Scientific, LLC?
Amy N. Chen and Jonah S. Ufferfilge are named on this Form 483, for the inspection of Mar 27 – Apr 6, 2023. Each investigator has a profile showing what they cite most.
When was Afton Scientific, LLC inspected by FDA?
The inspection ran Mar 27 – Apr 6, 2023, and the Form 483 is dated April 6, 2023.
How do I get the full Form 483 for Afton Scientific, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.