Overview
- 6 public-safe observations are available for this inspection.
- 5 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.
4 Jun 2019
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by Brandon J Brookens, Maureen A Wentzel
4 Jun 2019
21 CFR 117.35(a)
Sanitary Operations - Plant Sanitation
Cited by Brandon J Brookens, Maureen A Wentzel
4 Jun 2019
21 CFR 117.35(d)
Sanitation of food contact surfaces - frequency
Cited by Brandon J Brookens, Maureen A Wentzel
4 Jun 2019
21 CFR 117.35(e)
Sanitation of non-food contact surfaces - frequency
Cited by Brandon J Brookens, Maureen A Wentzel
Inspected site
IMIRA MIDDLESWARTH & SON, INCMiddleburg, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.126(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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