Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-03-31.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Mar 2015 – 31 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2012 | Not recorded | 483 | View 483 → |
| 3 Jan 2011 | Not recorded | WL | View 483 → |
| 18 May 2010 | Not recorded | 483 | View 483 → |
| 7 Jan 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Jan 2012
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Jude C Dike, Linda Linh T Nguyen
3 Jan 2011
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Lydia S Chan
Investigators
FDA investigators tied to this site in the record.
Mark E Chan2 insp.
Alla Dubrovsky1 insp.
Jude C Dike1 insp.
Linda Linh T Nguyen1 insp.
Lydia S Chan1 insp.
Roberta K Smith1 insp.
John A Liu1 insp.
Sergio Chavez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind International Immuno-Diagnostics Inc.'s 4 Form 483s
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