Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Nov 2014
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Michelle M Noe Varga, Michelle M Noe
Inspected site
SPSteven P. Treon, M.D., PhDBoston, United States
Inspection team
MMMichelle M Noe Varga
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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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