Afton Scientific, LLC
Form 483 issued May 8, 2024 · Charlottesville, Virginia
- Inspection
- Apr 30 – May 8, 2024
- Investigators
- Brentley Collins· Laurel A. Beer
- Observations
- 4
- Pages
- 5
- FEI number
- 1000123236
In short: On May 8, 2024, FDA issued a Form 483 with 4 observations to Afton Scientific, LLC in Charlottesville, Virginia (FEI 1000123236) after an inspection that ran Apr 30 – May 8, 2024. The investigators were Brentley Collins and Laurel A. Beer. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Establishment of the reliability of the container and closure supplier's report of analyses is deficient in…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Afton Scientific, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Afton Scientific, LLC?
Brentley Collins and Laurel A. Beer are named on this Form 483, for the inspection of Apr 30 – May 8, 2024. Each investigator has a profile showing what they cite most.
When was Afton Scientific, LLC inspected by FDA?
The inspection ran Apr 30 – May 8, 2024, and the Form 483 is dated May 8, 2024.
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.