Overview
- 4 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.
12 Jun 2009
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Ryan J Benedict
12 Jun 2009
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Ryan J Benedict
12 Jun 2009
21 CFR 820.90(b)(1)
Documentation of disposition, justification, signature
Cited by Ryan J Benedict
Inspected site
BOBecker Orthopedic Appliance Co.Troy, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(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 4 observations
The source PDF and 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