Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 May 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Nicholas L Hunt, Mercedes N Overton
8 May 2026
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Nicholas L Hunt, Mercedes N Overton
8 May 2026
21 CFR 211.166(a)
Lack of written stability program
Cited by Nicholas L Hunt, Mercedes N Overton
8 May 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Nicholas L Hunt, Mercedes N Overton
8 May 2026
21 CFR 211.42(c)(5)
Mfg / Processing Operations Area
Cited by Nicholas L Hunt, Mercedes N Overton
Inspected site
SCSombra Cosmetics, IncAlbuquerque, United States
Inspection team
MNMercedes N Overton
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(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