Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-05-24.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 May 2019 – 24 May 2019 | Human Drugs | Clean | |
| 10 Apr 2019 – 12 Apr 2019 | Human Drugs | 483 | On file |
| 16 Feb 2015 – 20 Feb 2015 | Human Drugs | 483 | View 483 → |
| 28 Sep 2011 | Not recorded | 483 | View 483 → |
| 15 Apr 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Feb 2015
21 CFR 211.194(a)(6)
Test results, comparison with standards not included
Cited by Gayle S Lawson, David J Eide
28 Sep 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Christopher T Middendorf
28 Sep 2011
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Christopher T Middendorf
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Amir Alavi1 insp.
Jamie L Dion1 insp.
Gayle S Lawson1 insp.
David J Eide1 insp.
Christopher T Middendorf1 insp.
Vlada Matusovsky1 insp.
Cynthia J Lee1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Redox Srl's 4 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