Afton Scientific, LLC
Form 483 issued October 6, 2023 · Charlottesville, Virginia
- Inspection
- Oct 3 – Oct 6, 2023
- Investigators
- Cody D. Rickman· Thomas R. Withers
- Observations
- 8
- Pages
- 8
- FEI number
- 1000123236
In short: On October 6, 2023, FDA issued a Form 483 with 8 observations to Afton Scientific, LLC in Charlottesville, Virginia (FEI 1000123236) after an inspection that ran Oct 3 – Oct 6, 2023. The investigators were Cody D. Rickman and Thomas R. Withers. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 04
Employees engaged in the processing of a drug product lack the education, training and experience required…
This inspection in context
Cody D. Rickman
8 documents · 2011–2026
Cites 211.100 (written procedures; deviations) 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Afton Scientific, LLC?
FDA listed 8 observations on this Form 483, mostly about production, quality system and food CGMP / preventive controls. The opening words of each observation are shown on this page.
Who inspected Afton Scientific, LLC?
Cody D. Rickman and Thomas R. Withers are named on this Form 483, for the inspection of Oct 3 – Oct 6, 2023. Each investigator has a profile showing what they cite most.
When was Afton Scientific, LLC inspected by FDA?
The inspection ran Oct 3 – Oct 6, 2023, and the Form 483 is dated October 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.