Thorn BioScience
Form 483 issued May 22, 2024 · Louisville, Kentucky
- Inspection
- May 14 – May 22, 2024
- Investigator
- Rafeeq Habeeb
- Observations
- 1
- Pages
- 24
- FEI number
- 3004471600
In short: On May 22, 2024, FDA issued a Form 483 with 1 observation to Thorn BioScience in Louisville, Kentucky (FEI 3004471600) after an inspection that ran May 14 – May 22, 2024. The investigator was Rafeeq Habeeb. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Rafeeq Habeeb
20 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thorn BioScience?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Thorn BioScience?
Rafeeq Habeeb is named on this Form 483, for the inspection of May 14 – May 22, 2024. Each investigator has a profile showing what they cite most.
When was Thorn BioScience inspected by FDA?
The inspection ran May 14 – May 22, 2024, and the Form 483 is dated May 22, 2024.
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.