Overview
- 8 public-safe observations are available for this inspection.
- 7 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.
16 Dec 2025
21 CFR 1271.55(a)(2)
Eligibility statement--basis of determination
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 211.130
Procedures are written, and followed
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 211.137(d)
Expiration date location on labeling
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 211.150(b)
Distribution Recall System
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 211.150(b)
Recall facilitation
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
Inspected site
RSRegen Suppliers LLCScottsdale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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