Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-01-14.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jan 2016 – 14 Jan 2016 | Human Drugs | Clean | |
| 5 Feb 2015 – 10 Mar 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2015
21 CFR 312.60
FD-1572, protocol compliance
Cited by Diane C Van Leeuwen, Ka L Wong, Trushani T Desai, Lanita F Kelley
10 Mar 2015
21 CFR 312.62(a)
Accountability records
Cited by Diane C Van Leeuwen, Ka L Wong, Trushani T Desai, Lanita F Kelley
10 Mar 2015
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Diane C Van Leeuwen, Ka L Wong, Trushani T Desai, Lanita F Kelley
Investigators
FDA investigators tied to this site in the record.
James R Fleckenstein1 insp.
Diane C Van Leeuwen1 insp.
Ka L Wong1 insp.
Trushani T Desai1 insp.
Lanita F Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Raffi R. Minasian, M.D.'s 1 Form 483
Source PDFs, 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