Overview
- 11 public-safe observations are available for this inspection.
- 10 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.
1 Feb 2019
21 CFR 117.165(b)
Process Controls Verif Procedures: Establish Implement
Cited by Rashonda N Rucker, Myckie M Jacobsen, Alphonso A Haupt
1 Feb 2019
21 CFR 117.415(a)(1)
Supply-Chain Supplier Approval
Cited by Rashonda N Rucker, Myckie M Jacobsen, Alphonso A Haupt
1 Feb 2019
21 CFR 117.130(a)(2)
Hazard Analysis - Written
Cited by Rashonda N Rucker, Myckie M Jacobsen, Alphonso A Haupt
1 Feb 2019
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Rashonda N Rucker, 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 117.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.130(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.305 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.415(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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