Overview
- 4 public-safe observations are available for this inspection.
- 3 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.
11 Jul 2018
21 CFR 112.145(e)
Corrective action components of an environmental monitoring
Cited by Pablo Alcantara
11 Jul 2018
21 CFR 112.147(a)
Written sampling plan for spent irrigation water or sprouts
Cited by Pablo Alcantara
11 Jul 2018
21 CFR 112.145(e)
Corrective action components of an environmental monitoring plan
Cited by Pablo Alcantara
Inspected site
BFBloomsbury Farm LLCSmyrna, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 112.145(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 112.147(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.42(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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