Overview
- 9 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.
31 Oct 2017
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by James Betz, Myckie M Jacobsen, Alphonso A Haupt
31 Oct 2017
21 CFR 117.35(b)(2)
Toxic Chemicals - identified, held, stored
Cited by James Betz, Myckie M Jacobsen, Alphonso A Haupt
31 Oct 2017
21 CFR 117.37
Sanitary Facilities and Control
Cited by James Betz, Myckie M Jacobsen, Alphonso A Haupt
31 Oct 2017
21 CFR 117.20(b)
Plant Construction and Design
Cited by James Betz, Myckie M Jacobsen, Alphonso A Haupt
Inspected site
IGIacofano's Group LLCCharleston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.37 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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