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.
2 Dec 2009
21 CFR 812.110(b)
Investigator non-compliance with agreement/plan/regulations
Cited by Barbara A Rusin
Inspected site
MJMiguelangelo J. Perez-Cruet, M.D., M.S.Waterford Township, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 50.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.36(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
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