Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-06.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Sep 2023 – 6 Oct 2023 | Human Drugs | 483 | View 483 → |
| 28 Mar 2022 – 6 Apr 2022 | Human Drugs | WL | View 483 → |
| 10 Feb 2020 – 19 Feb 2020 | Human Drugs | 483 | View 483 → |
| 13 Aug 2018 – 17 Aug 2018 | Human Drugs | 483 | View 483 → |
| 20 Jun 2016 – 24 Jun 2016 | Human Drugs | 483 | View 483 → |
| 4 Aug 2014 – 8 Aug 2014 | Human Drugs | 483 | View 483 → |
| 10 Sep 2013 – 16 Sep 2013 | Human Drugs | Clean | |
| 8 Jun 2012 | Not recorded | Clean | |
| 2 Sep 2010 | Not recorded | Clean | |
| 4 Sep 2009 | Not recorded | Clean | |
| 17 Sep 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Oct 2023
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Carrie A Hughes, Nicholas L Hunt
6 Oct 2023
21 CFR 211.192
Written record of investigation incomplete
Cited by Carrie A Hughes, Nicholas L Hunt
6 Oct 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Carrie A Hughes, Nicholas L Hunt
6 Oct 2023
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Carrie A Hughes, Nicholas L Hunt
Investigators
FDA investigators tied to this site in the record.
Timothy T Kapsala4 insp.
Carrie A Hughes3 insp.
Nicholas L Hunt2 insp.
Linda Thai2 insp.
Seneca D Toms1 insp.
Lesley K Satterwhite1 insp.
Michael T Cyrus1 insp.
Zachary L Stamm1 insp.
Jamie L Dion1 insp.
Carla J Lundi1 insp.
Ivis L Negron Torres1 insp.
Linda F Murphy1 insp.
Daniel J Roberts1 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 | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | 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)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ROIS Phoenix 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