Overview
- 6 public-safe observations are available for this inspection.
- 4 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.
21 Aug 2019
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by James P Stallings
21 Aug 2019
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by James P Stallings
21 Aug 2019
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by James P Stallings
Inspected site
BSBxter Services, LLCFort Mohave, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | 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