Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-17.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jan 2020 – 17 Jan 2020 | Human Drugs | 483 | View 483 → |
| 24 Jul 2017 – 3 Aug 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Absence of Written Procedures
Cited by Uttaniti Limchumroon, Jeffrey P Raimondi, Chiaochun J Wang, Kouros Kangarli
Control procedures to monitor and validate performance
Cited by Uttaniti Limchumroon, Jeffrey P Raimondi, Chiaochun J Wang, Kouros Kangarli
Procedures for sterile drug products
Cited by Uttaniti Limchumroon, Jeffrey P Raimondi, Chiaochun J Wang, Kouros Kangarli
Scientifically sound laboratory controls
Cited by Uttaniti Limchumroon, Jeffrey P Raimondi, Chiaochun J Wang, Kouros Kangarli
Environmental Monitoring System
Cited by Uttaniti Limchumroon, Jeffrey P Raimondi, Chiaochun J Wang, Kouros Kangarli
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 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Intarcia Therapeutics, Inc.'s 2 Form 483s
Source PDFs 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