Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
13 Feb 2023
21 CFR 507.105(a)(1)
Supply-Chain Program Establish and Implement
Cited by Nicholas E Boyd, Hassan M Fakhreddine
13 Feb 2023
21 CFR 507.25(c)(2)
Manufacturing, Processing, Packing, Holding - Measures
Cited by Nicholas E Boyd, Hassan M Fakhreddine
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 507.14 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.25(c)(2) | 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 507.49(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, 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