Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-07-31.
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 |
|---|---|---|---|
| 29 Jul 2024 – 31 Jul 2024 | Human Drugs | Clean | |
| 11 Mar 2019 – 22 Mar 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Mar 2019
21 CFR 312.50
General responsibilities of sponsors
Cited by Iram R Hassan, Diane C Van Leeuwen, Bei Yu, Ni A Khin
22 Mar 2019
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Iram R Hassan, Diane C Van Leeuwen, Bei Yu, Ni A Khin
Investigators
FDA investigators tied to this site in the record.
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 | 2x |
Full site report
Get the verbatim findings behind Intra-Cellular Therapies Inc'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