Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
31 Jul 2015
21 CFR 111.105
Ensure quality; package, labeled, master record
Cited by Elizabeth S Howell, Maria P Kelly-Doggett
31 Jul 2015
21 CFR 111.105(h)
Quality control - production, process control
Cited by Elizabeth S Howell, Maria P Kelly-Doggett
31 Jul 2015
21 CFR 111.10(b)(9)
Contamination - extraneous materials
Cited by Elizabeth S Howell, Maria P Kelly-Doggett
31 Jul 2015
21 CFR 111.15(i)
Hand-washing facilities
Cited by Elizabeth S Howell, Maria P Kelly-Doggett
Inspected site
EIEclectic Institute IncGresham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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