Overview
- 5 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
19 Aug 2011
21 CFR 110.35(a)
Buildings/sanitary
Cited by James P Stallings, Natalie J Ayoub, Ademola O Daramola, Jorge M Ruano-Rossil, John C Sedwick
19 Aug 2011
21 CFR 110.35(c)
Insecticides/rodenticides
Cited by James P Stallings, Natalie J Ayoub, Ademola O Daramola, Jorge M Ruano-Rossil, John C Sedwick
19 Aug 2011
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by James P Stallings, Natalie J Ayoub, Ademola O Daramola, Jorge M Ruano-Rossil, John C Sedwick
19 Aug 2011
21 CFR 110.80
Testing
Cited by James P Stallings, Natalie J Ayoub, Ademola O Daramola, Jorge M Ruano-Rossil, John C Sedwick
19 Aug 2011
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by James P Stallings, Natalie J Ayoub, Ademola O Daramola, Jorge M Ruano-Rossil, John C Sedwick
Inspected site
BPBonaterra Products, Inc.South El Monte, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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