Overview
- 7 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.
12 Sep 2025
21 CFR 507.105(a)(1)
Supply-Chain Program Establish and Implement
Cited by Christi L Bellmore
12 Sep 2025
21 CFR 507.25(c)(1)
Manufacturing, Processing, Packing, Holding Operations
Cited by Christi L Bellmore
12 Sep 2025
21 CFR 507.42(a)(1)
Establishment and Implementation of Corrective Action Procedures
Cited by Christi L Bellmore
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 507.25(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.34(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.40(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.42(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.49(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.49(b)(3) | 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 7 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