RTP Operating, LLC
FDA inspection history in Durham, 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 Durham, North Carolina.
Cited most
Across all RTP Operating observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete RTP Operating file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Durham, North Carolina
One Form 483 · 2024 · 5 observations
Latest: Form 483, Feb 16, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-16 | 483 Form 483 | Durham, North Carolina | 5 | $99 |
Investigators on these documents
Anna Kwilas (1)Jie He (1)Laura Demaster (1)Shannila Shrestha (1)
FEI number 3015451326 · most recent document Feb 16, 2024
About RTP Operating, LLC
How many FDA Form 483s has RTP Operating, LLC received?
FDA Intel has 1 Form 483 on file for RTP Operating, LLC; the most recent is dated Feb 16, 2024.
When was RTP Operating, LLC last inspected by FDA?
The most recent FDA inspection document on file for RTP Operating, LLC is a Form 483 dated Feb 16, 2024, for the site in Durham, North Carolina.
What did FDA cite at RTP Operating, LLC?
The regulations cited most in the observations on file for RTP Operating, LLC are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time.