Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-03-25.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2016 – 25 Mar 2016 | Human Drugs | 483 | View 483 → |
| 22 Sep 2015 – 23 Sep 2015 | Human Drugs | Clean | |
| 17 Jun 2013 – 11 Jul 2013 | Human Drugs | Clean | |
| 21 Sep 2011 | Not recorded | Clean | |
| 29 Sep 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2016
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Doan T Nguyen, Virgilio F Pacio
Investigators
FDA investigators tied to this site in the record.
Linda Thai2 insp.
Doan T Nguyen1 insp.
Virgilio F Pacio1 insp.
Joey V Quitania1 insp.
Thomas R Beilke1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Prometheus Laboratories Inc.'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