Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
21 Mar 2025
21 CFR 58.113(a)(1)
Mixtures: uniformity and concentration
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
21 Mar 2025
21 CFR 58.185(c)
Final report: corrections or additions
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
21 Mar 2025
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
21 Mar 2025
21 CFR 58.35(b)(6)
QAU: review final study report
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton
Inspected site
HPHealth Partners Neuroscience Center Research and InnovationSaint Paul, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(g) | 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