Overview
- 22 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-31.
At a glance
Inspections
22
Form 483s
9
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2020 – 31 Jan 2020 | Human Drugs | Clean | |
| 13 Aug 2018 – 17 Aug 2018 | Human Drugs | 483 | View 483 → |
| 16 Oct 2017 – 20 Oct 2017 | Human Drugs | 483 | View 483 → |
| 8 Feb 2017 – 13 Feb 2017 | Foods & Cosmetics | Clean | |
| 5 Dec 2016 – 13 Dec 2016 | Human Drugs | 483 | View 483 → |
| 7 Jul 2014 – 11 Jul 2014 | Human Drugs | 483 | View 483 → |
| 5 Mar 2013 – 8 Mar 2013 | Human Drugs | 483 | On file |
| 9 Apr 2012 | Not recorded | 483 | View 483 → |
| 5 May 2011 | Not recorded | Clean | |
| 22 Apr 2010 | Not recorded | Clean | |
| 2 Apr 2010 | Not recorded | WL | On file |
| 28 Jan 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Aug 2018
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Angela Shepas, Richard A Abate
17 Aug 2018
21 CFR 314.80(c)(2)(ii)(A)
Incomplete periodic safety report
Cited by Angela Shepas, Richard A Abate
17 Aug 2018
21 CFR 314.80(g)(1)
Failure to submit electronic format safety report
Cited by Angela Shepas, Richard A Abate
20 Oct 2017
21 CFR 211.130(e)
Packaging line inspection documentation
Cited by Bryan A Galvez, Truong X Nguyen, Christopher D Washington, Vioela J Caze
Investigators
FDA investigators tied to this site in the record.
Binh T Nguyen4 insp.
Joey V Quitania2 insp.
Bryan A Galvez2 insp.
Yvonne T Lacour2 insp.
Vashti E Bocker2 insp.
Kham Phommachanh2 insp.
Christopher M Jenner1 insp.
Angela Shepas1 insp.
Richard A Abate1 insp.
Truong X Nguyen1 insp.
Christopher D Washington1 insp.
Vioela J Caze1 insp.
Sean P Desbrow1 insp.
Carrie A Hughes1 insp.
Liming Zhang1 insp.
Cassandra L Abellard1 insp.
Natalie J Ayoub1 insp.
Michael D Garcia1 insp.
Richmond K Yip1 insp.
Cntrctmntr Nepsa1 insp.
Tara L Stockton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.120(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nexgen Pharma Inc's 9 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