Overview
- 33 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Jun 2016
21 CFR 111.103
Written procedures - quality control operations
Cited by Christopher D Snyder
8 Jun 2016
21 CFR 111.103
Written procedures - quality control operations
Cited by Christopher D Snyder
8 Jun 2016
21 CFR 111.103
Written procedures - quality control operations
Cited by Christopher D Snyder
Inspected site
EAEden's Answers IncHolmesville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.10(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.210(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.210(h)(3)(ii)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.260(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.260(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 33 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