Overview
- 14 public-safe observations are available for this inspection.
- 7 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 Oct 2018
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Siobhan A Gallagher
11 Oct 2018
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Siobhan A Gallagher
11 Oct 2018
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Siobhan A Gallagher
11 Oct 2018
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Siobhan A Gallagher
Inspected site
BWByron White Formulas, Inc.Santa Rosa, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 14 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