Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
13 Apr 2022
21 CFR 111.20(a)
Physical plant - size, construction, design
Cited by Celia L Hutchinstein, Michael S Hudson, Keegan B Mixon
13 Apr 2022
21 CFR 111.70(a)
Specifications - manufacturing process
Cited by Celia L Hutchinstein, Michael S Hudson, Keegan B Mixon
13 Apr 2022
21 CFR 111.75(c)(3)
Specifications met limits on contamination ; basis
Cited by Celia L Hutchinstein, Michael S Hudson, Keegan B Mixon
13 Apr 2022
21 CFR 111.75(h)(2)
Tests, examinations - scientifically valid
Cited by Celia L Hutchinstein, Michael S Hudson, Keegan B Mixon
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 111.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | 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 4 observations
The full inspection record, as Atlas holds it, 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