Afton Scientific, LLC
Form 483 issued June 14, 2019 · Charlottesville, Virginia
- Investigators
- Gayle S. Lawson· William Leonard
- Observations
- 7
- Pages
- 5
- FEI number
- 1000123236
In short: On June 14, 2019, FDA issued a Form 483 with 7 observations to Afton Scientific, LLC in Charlottesville, Virginia (FEI 1000123236). The investigators were Gayle S. Lawson and William Leonard. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 03
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 0421 CFR 11
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Afton Scientific, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Afton Scientific, LLC?
Gayle S. Lawson and William Leonard are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Afton Scientific, LLC inspected by FDA?
This Form 483 is dated June 14, 2019.
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.