Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
4 Apr 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Gretchen M Laws, Michael Z Weigman
4 Apr 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Gretchen M Laws, Michael Z Weigman
4 Apr 2025
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Gretchen M Laws, Michael Z Weigman
Inspected site
ULUSAntibiotics LLCBristol, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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