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.
3 Sep 2015
21 CFR 225.130
Cleanliness, inspection, cleanout
Cited by Luckner Jean-Marie, Christian L Witkovskie
3 Sep 2015
21 CFR 225.142
Adequate procedures for Type A and Type B articles
Cited by Luckner Jean-Marie, Christian L Witkovskie
3 Sep 2015
21 CFR 225.165
Establishment and use of adequate procedures
Cited by Luckner Jean-Marie, Christian L Witkovskie
3 Sep 2015
21 CFR 225.180
Bagged or bulk deliveries
Cited by Luckner Jean-Marie, Christian L Witkovskie
3 Sep 2015
21 CFR 225.120
Vermin and pest infestation
Cited by Luckner Jean-Marie, Christian L Witkovskie
Inspected site
BNBurkmann Nutrition Inc.Danville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 225.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 225.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 225.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 225.165 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 225.180 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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