Indivior Manufacturing LLC
FDA inspection history in Raleigh, North Carolina, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Raleigh, North Carolina.
Cited most
Across all Indivior Manufacturing observations on file
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
The complete Indivior Manufacturing file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Raleigh, North Carolina
One Form 483 · 2024 · 6 observations
Latest: Form 483, Jan 18, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-18 | 483 Form 483 | Raleigh, North Carolina | 6 | $99 |
Investigators on these documents
FEI number 3005208599 · most recent document Jan 18, 2024
About Indivior Manufacturing LLC
How many FDA Form 483s has Indivior Manufacturing LLC received?
FDA Intel has 1 Form 483 on file for Indivior Manufacturing LLC; the most recent is dated Jan 18, 2024.
When was Indivior Manufacturing LLC last inspected by FDA?
The most recent FDA inspection document on file for Indivior Manufacturing LLC is a Form 483 dated Jan 18, 2024, for the site in Raleigh, North Carolina.
What did FDA cite at Indivior Manufacturing LLC?
The regulations cited most in the observations on file for Indivior Manufacturing LLC are 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.