Overview
- 6 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Dec 2023
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.81(a)
SOPs: authorization and documentation of deviations
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.81(a)
SOPs: laboratory methods
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
1 Dec 2023
21 CFR 58.81(a)
SOPs: authorization and documentation of deviations
Cited by Jeanne J Thai, Erin M Mcdowell, Yuanyuan Li
Inspected site
IRIIT Research InstituteChicago, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere