Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
19 Dec 2025
21 CFR 211.105(b)
Distinctive ID or code not recorded in batch record
Cited by Marla A Cassidy, William F Lagud
19 Dec 2025
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Marla A Cassidy, William F Lagud
19 Dec 2025
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Marla A Cassidy, William F Lagud
19 Dec 2025
21 CFR 211.194(c)
Testing and standardization of standards et. al.
Cited by Marla A Cassidy, William F Lagud
Inspected site
KIKaryoLogic IncDurham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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