Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
14 Apr 2026
21 CFR 211.166(a)(1)
Sample size - test intervals
Cited by Thuy Tram L Nguyen, Navneet Kaur
14 Apr 2026
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Thuy Tram L Nguyen, Navneet Kaur
14 Apr 2026
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Thuy Tram L Nguyen, Navneet Kaur
14 Apr 2026
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Thuy Tram L Nguyen, Navneet Kaur
14 Apr 2026
21 CFR 211.84(a)
Components withheld from use pending release
Cited by Thuy Tram L Nguyen, Navneet Kaur
Inspected site
KSKDC/ONE SOCAL LABORATORIES, LLCWalnut, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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