Overview
- 42 public-safe observations are available for this inspection.
- 20 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.
19 Aug 2016
21 CFR 110.10(b)(6)
Effective use of hair restraint
Cited by James Betz, Alphonso A Haupt, Hristu B Chepa
19 Aug 2016
21 CFR 110.10(b)(6)
Effective use of hair restraint
Cited by James Betz, Alphonso A Haupt, Hristu B Chepa
19 Aug 2016
21 CFR 110.10(b)(8)
Personal food/drink/tobacco
Cited by James Betz, Alphonso A Haupt, Hristu B Chepa
19 Aug 2016
21 CFR 110.10(b)(8)
Personal food/drink/tobacco
Cited by James Betz, Alphonso A Haupt, Hristu B Chepa
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 110.20(b)(4) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.10 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.9(c) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 42 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