Indivior Manufacturing LLC
Form 483 issued January 18, 2024 · Raleigh, North Carolina
- Inspection
- Jan 9 – Jan 18, 2024
- Investigator
- Latorie S. Jones
- Observations
- 6
- Pages
- 5
- FEI number
- 3005208599
In short: On January 18, 2024, FDA issued a Form 483 with 6 observations to Indivior Manufacturing LLC in Raleigh, North Carolina (FEI 3005208599) after an inspection that ran Jan 9 – Jan 18, 2024. The investigator was Latorie S. Jones. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 6 observations.
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
Written production and process control procedures are not followed in the execution of production…
- 03
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmIndivior Manufacturing LLC history
The site's inspection history, in date order.
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 Indivior Manufacturing LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Indivior Manufacturing LLC?
Latorie S. Jones is named on this Form 483, for the inspection of Jan 9 – Jan 18, 2024. Each investigator has a profile showing what they cite most.
When was Indivior Manufacturing LLC inspected by FDA?
The inspection ran Jan 9 – Jan 18, 2024, and the Form 483 is dated January 18, 2024.
How do I get the full Form 483 for Indivior Manufacturing 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.