Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
13 Mar 2009
21 CFR 820.70(a)(2)
Production monitoring and control
Cited by Sarah M Forney, Susan T Hadman, Dawn L Wydner
13 Mar 2009
21 CFR 1271.150(c)(1)(iii)
Ensurane of compliance
Cited by Sarah M Forney, Susan T Hadman, Dawn L Wydner
13 Mar 2009
21 CFR 1271.195(c)
Monitoring--cross contamination, exposure to CD
Cited by Sarah M Forney, Susan T Hadman, Dawn L Wydner
13 Mar 2009
21 CFR 1271.220(c)
Specified requirements for in-process controls
Cited by Sarah M Forney, Susan T Hadman, Dawn L Wydner
Inspected site
MTMusculoskeletal Transplant Foundation, Inc.Edison, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.150(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.220(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a)(2) | 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