Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-09-12.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Sep 2018 – 12 Sep 2018 | Human Drugs | 483 | View 483 → |
| 9 Jul 2014 – 17 Jul 2014 | Human Drugs | Clean | |
| 13 Jul 2012 | Not recorded | 483 | On file |
| 25 Mar 2011 | Not recorded | Clean | |
| 29 Jul 2009 | Not recorded | Clean | |
| 16 Feb 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jeffrey M Watson2 insp.
Doan T Nguyen1 insp.
John A Gonzalez1 insp.
Alicia K Mckinsey1 insp.
Lance M De Souza1 insp.
Henry K Lau1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Solstice Neurosciences LLC's 2 Form 483s
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