Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-14.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2024 – 14 Jun 2024 | Human Drugs | 483 | View 483 → |
| 19 Aug 2019 – 22 Aug 2019 | Human Drugs | 483 | View 483 → |
| 18 Jun 2018 – 22 Jun 2018 | Human Drugs | 483 | View 483 → |
| 12 Feb 2018 – 16 Feb 2018 | Human Drugs | 483 | View 483 → |
| 21 Dec 2015 – 23 Dec 2015 | Human Drugs | 483 | View 483 → |
| 8 Mar 2012 | Not recorded | 483 | View 483 → |
| 20 Jul 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Aug 2019
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Karen L Kosar, Joanne M Schlossin
Investigators
FDA investigators tied to this site in the record.
Karen L Kosar2 insp.
Jay B Shah1 insp.
Joanne M Schlossin1 insp.
Jay T Wong1 insp.
Diane E Bruce1 insp.
Sony Mathews1 insp.
Mindy M Chou1 insp.
Chad N Thompson1 insp.
James D Bridges1 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 | 8x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.80(f)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(f)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 329.100(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind XGen Pharmaceuticals DJB, Inc.'s 6 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