Thorn BioScience
Form 483 issued May 26, 2023 · Louisville, Kentucky
- Investigator
- Logan T. Williams
- Observations
- 2
- Pages
- 3
- FEI number
- 3004471600
In short: On May 26, 2023, FDA issued a Form 483 with 2 observations to Thorn BioScience in Louisville, Kentucky (FEI 3004471600). The investigator was Logan T. Williams. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160(a) (1×) · 211.180(e)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by…
- 02
Written procedures are not followed for evaluations conducted at least (1) (4)) to review records associated…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmThorn BioScience history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thorn BioScience?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Thorn BioScience?
Logan T. Williams is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Thorn BioScience inspected by FDA?
This Form 483 is dated May 26, 2023.
How do I get the full Form 483 for Thorn BioScience?
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.