Thorn BioScience
Form 483 issued June 7, 2019 · Louisville, Kentucky
- Investigator
- Doan T. Nguyen
- Observations
- 4
- Pages
- 4
- FEI number
- 3004471600
In short: On June 7, 2019, FDA issued a Form 483 with 4 observations to Thorn BioScience in Louisville, Kentucky (FEI 3004471600). The investigator was Doan T. Nguyen. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The statistical quality control criteria fail to include appropriate acceptance…
- 03
Laboratory records are deficient in that they do not include the initials and signature of the…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
This inspection in context
Doan T. Nguyen
8 documents · 2014–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Germany.
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 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thorn BioScience?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Thorn BioScience?
Doan T. Nguyen 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 June 7, 2019.
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.