Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
21 May 2026
21 CFR 211.105(a)
Identification of containers, lines, equipment
Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton
21 May 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton
21 May 2026
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton
21 May 2026
21 CFR 211.184(c)
Individual inventory record
Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton
21 May 2026
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton
Inspected site
KBKedrion Biopharma Inc.Melville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 601.12(b) | 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