Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
15 May 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.165(b)
Microbiological testing
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
Inspected site
UMUnither Manufacturing LLC.Rochester, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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(b) | 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