Simtra US LLC
FDA inspection history in Bloomington, Indiana, 2018 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2021: one Form 483; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Bloomington, Indiana.
- 2021One Form 483, at Bloomington, Indiana.
- 2024Two Form 483s, at Bloomington, Indiana.
- 2024The longest 483 on file: 7 observations over 9 pages at Bloomington, Indiana.
Cited most
Across all Simtra US observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
The complete Simtra US file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bloomington, Indiana
Four Form 483s · 2018 to 2024 · 15 observations
Latest: Form 483, Jul 26, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-26 | 483 Form 483 | Bloomington, Indiana | 1 | $99 |
| 2024-02-20 | 483 Form 483 | Bloomington, Indiana | 7 | $99 |
| 2021-11-10 | 483 Form 483 | Bloomington, Indiana | 3 | $99 |
| 2018-05-23 | 483 Form 483 | Bloomington, Indiana | 4 | $99 |
Investigators on these documents
Brentley Collins (1)Burnell M. Henry (1)Laurimer Kuilan-Torres (1)Ruo H. Xu (1)Scott Ballard (1)Simone E. Pitts (1)Susan M. Jackson (1)Xiuju Lu (1)Yiwei Li (1)
FEI number 1000115571 · most recent document Jul 26, 2024
About Simtra US LLC
How many FDA Form 483s has Simtra US LLC received?
FDA Intel has 4 Form 483s on file for Simtra US LLC; the most recent is dated Jul 26, 2024.
When was Simtra US LLC last inspected by FDA?
The most recent FDA inspection document on file for Simtra US LLC is a Form 483 dated Jul 26, 2024, for the site in Bloomington, Indiana.
What did FDA cite at Simtra US LLC?
The regulations cited most in the observations on file for Simtra US LLC are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times.