Overview
- 4 public-safe observations are available for this inspection.
- 3 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 Aug 2012
21 CFR 312.53(c)(1)
Investigator statement (FDA 1572)
Cited by Vashti E Bocker, Lynette M Terry
3 Aug 2012
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Vashti E Bocker, Lynette M Terry
Inspected site
ASAndrew SchreiberOrange, United States
Inspection team
VEVashti E Bocker
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.53(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(b) | 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