Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
7 Aug 2009
21 CFR 110.10(c)
Training of handlers and supervisors
Cited by Mancia R Walker, Amanda L Evanco, Richard L Garcia
7 Aug 2009
21 CFR 110.35(b)(1)
Safe and adequate for use
Cited by Mancia R Walker, Amanda L Evanco, Richard L Garcia
7 Aug 2009
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Mancia R Walker, Amanda L Evanco, Richard L Garcia
7 Aug 2009
21 CFR 110.80
Reasonable precautions
Cited by Mancia R Walker, Amanda L Evanco, Richard L Garcia
Inspected site
SCSeacon CorporationCharlotte, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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