FEI 3006750659
FDA inspection history in Centennial, Colorado, 2008
- 1
- Form 483
- 1
- EIR
Every document, by year
- Form 483
- EIR
2008: one Form 483 and one inspection report.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One Form 483 and one inspection report, at Centennial, Colorado.
Cited most
Across all site observations on file
- 21 CFR 312.60General responsibilities of investigators1
- 21 CFR 312.62Investigator recordkeeping and record retention1
- 21 CFR 312.66Assurance of IRB review1
- 21 CFR 50.20General requirements for informed consent1
The complete site file.
All 2 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
Centennial, Colorado
One Form 483 and one inspection report · 2008 · 4 observations
Latest: Form 483, May 7, 2008 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2008-05-07 | 483 Form 483 | Centennial, Colorado | 4 | $99 |
| 2008-05-07 | EIR EIR | Centennial, Colorado | — | $550 |
Investigators on these documents
FEI number 3006750659 · most recent document May 7, 2008
About FEI 3006750659
How many FDA Form 483s has FEI 3006750659 received?
FDA Intel has 1 Form 483 on file for FEI 3006750659; the most recent is dated May 7, 2008.
When was FEI 3006750659 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3006750659 is a Form 483 dated May 7, 2008, for the site in Centennial, Colorado.
What did FDA cite at FEI 3006750659?
The regulations cited most in the observations on file for FEI 3006750659 are 21 CFR 312.60 (General responsibilities of investigators), 1 time; 21 CFR 312.62 (Investigator recordkeeping and record retention), 1 time; 21 CFR 312.66 (Assurance of IRB review), 1 time.