Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-12.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Dec 2024 – 12 Dec 2024 | Biologics | 483 | View 483 → |
| 21 Nov 2016 – 22 Nov 2016 | Biologics | 483 | View 483 → |
| 28 May 2014 – 29 May 2014 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Dec 2024
21 CFR 1271.260(e)
Storage temperatures recorded, maintained
Cited by Elisa M Fleming, Nerming V Briones
12 Dec 2024
21 CFR 1271.270(a)
Records maintained concurrently
Cited by Elisa M Fleming, Nerming V Briones
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 1271.265(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.190(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind IndeCon, Inc.'s 3 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