Afton Scientific, LLC
Form 483 issued October 22, 2021 · Charlottesville, Virginia
- Inspection
- Oct 18 – Oct 22, 2021
- Investigators
- Kristina L. Conroy· Saleem A. Akhtar
- Observations
- 2
- Pages
- 4
- FEI number
- 1000123236
In short: On October 22, 2021, FDA issued a Form 483 with 2 observations to Afton Scientific, LLC in Charlottesville, Virginia (FEI 1000123236) after an inspection that ran Oct 18 – Oct 22, 2021. The investigators were Kristina L. Conroy and Saleem A. Akhtar. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.42 (1×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods…
This inspection in context
Kristina L. Conroy
10 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Afton Scientific, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Afton Scientific, LLC?
Kristina L. Conroy and Saleem A. Akhtar are named on this Form 483, for the inspection of Oct 18 – Oct 22, 2021. Each investigator has a profile showing what they cite most.
When was Afton Scientific, LLC inspected by FDA?
The inspection ran Oct 18 – Oct 22, 2021, and the Form 483 is dated October 22, 2021.
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.