Overview
- 3 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Sep 2022
21 CFR 80.37
Treatment of batch pending certification
Cited by Bhakti Petigara Harp, Kimberlee A Ewing, Bryan K Bowes
15 Sep 2022
21 CFR 80.37
Treatment of batch pending certification
Cited by Bhakti Petigara Harp, Kimberlee A Ewing, Bryan K Bowes
15 Sep 2022
21 CFR 80.37
Treatment of batch pending certification
Cited by Bhakti Petigara Harp, Kimberlee A Ewing, Bryan K Bowes
Inspected site
RURoha USA, LLCSaint Louis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 80.37 | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 3 observations
The full inspection record, as Atlas holds it, 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