Overview
- 26 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Inspected site
WDWaterfront Development Corporation/BroaddusLouisville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.33(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.34 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.67 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.82(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.82(e) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 26 observations
Every observation in full, 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