Overview
- 5 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 May 2024
21 CFR 507.105(a)(1)
Supply-Chain Program Establish and Implement
Cited by Antonio M Hampton, Brian J Davis
3 May 2024
21 CFR 507.40(c)(1)
Monitoring Records for Preventive Controls
Cited by Antonio M Hampton, Brian J Davis
Inspected site
BBBest Buy Bones Inc.Mount Morris, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 507.105(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.34(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.34(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.40(c)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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