Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
12
Form 483s
5
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2026 – 15 May 2026 | Human Drugs | 483 | On file |
| 20 Aug 2024 – 23 Aug 2024 | Human Drugs | Clean | |
| 11 Apr 2022 – 15 Apr 2022 | Human Drugs | 483 | View 483 → |
| 25 May 2021 – 27 May 2021 | Biologics | 483 | View 483 → |
| 3 May 2016 – 4 May 2016 | Medical Devices & Rad Health | Clean | |
| 7 Oct 2014 – 9 Oct 2014 | Medical Devices & Rad Health | 483 | On file |
| 19 Nov 2012 | Not recorded | Clean | |
| 9 Jun 2011 | Not recorded | Clean | |
| 3 Sep 2008 | Not recorded | 483 | On file |
| 18 May 2006 | Not recorded | Clean | |
| 11 Oct 2002 | Not recorded | Clean | |
| 8 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Apr 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Sony Mathews, Syeda N Mahazabin, Sayyem H Akbar
15 Apr 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Sony Mathews, Syeda N Mahazabin, Sayyem H Akbar
15 Apr 2022
21 CFR 211.192
Written record of investigation incomplete
Cited by Sony Mathews, Syeda N Mahazabin, Sayyem H Akbar
15 Apr 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sony Mathews, Syeda N Mahazabin, Sayyem H Akbar
15 Apr 2022
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Sony Mathews, Syeda N Mahazabin, Sayyem H Akbar
Investigators
FDA investigators tied to this site in the record.
Nicholas C Mendiola3 insp.
Lauren H Augustyniak1 insp.
Roberto A Dookhan1 insp.
Sony Mathews1 insp.
Syeda N Mahazabin1 insp.
Sayyem H Akbar1 insp.
Benton M Ketron1 insp.
Matthew D Schnittker1 insp.
Karen L Kosar1 insp.
Kim M Downing1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | 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)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.51 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Canyon Rush, LLC's 5 Form 483s
Source PDFs 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