Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2015-08-13.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jul 2015 – 13 Aug 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Aug 2015
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Douglas Fiorentino, Brunilda Torres
Investigators
FDA investigators tied to this site in the record.
Douglas Fiorentino1 insp.
Brunilda Torres1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind James McDonough, M.D.'s 1 Form 483
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat