Overview
- 40 public-safe observations are available for this inspection.
- 35 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.
29 Nov 2010
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Brian P Emanuel, Janae D Price
29 Nov 2010
21 CFR 110.10(c)
Training of handlers and supervisors
Cited by Brian P Emanuel, Janae D Price
Inspected site
EEE.P.I. Eden Processing, Inc.Poplar Grove, United States
Inspection team
BPBrian P Emanuel
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 | 2x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 40 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