Overview
- 14 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-11.
At a glance
Inspections
14
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jul 2025 – 11 Jul 2025 | Human Drugs | 483 | View 483 → |
| 13 Feb 2024 – 15 Feb 2024 | Medical Devices & Rad Health | Clean | |
| 3 Jun 2019 – 7 Jun 2019 | Human Drugs | 483 | View 483 → |
| 25 Jun 2018 – 29 Jun 2018 | Human Drugs | Clean | |
| 2 Jun 2016 – 1 Sep 2016 | Human Drugs | WL | View 483 → |
| 12 Dec 2013 – 15 Jan 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Nov 2011 | Not recorded | 483 | View 483 → |
| 1 Oct 2009 | Not recorded | 483 | View 483 → |
| 23 Jul 2009 | Not recorded | 483 | On file |
| 10 Jul 2008 | Not recorded | WL | On file |
| 8 Sep 2006 | Not recorded | Clean | |
| 26 Jan 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Jun 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Emilie Kahn, Vioela J Caze
1 Sep 2016
21 CFR 211.165(e)
Test methods
Cited by That Q Dang, Debra I Love, Brittani N Franklin, Christopher D Leach, Nicholas P Diorio, Michael E Maselli
Investigators
FDA investigators tied to this site in the record.
Bruce H Mccullough3 insp.
Debra I Love2 insp.
Nicholas P Diorio2 insp.
Wenzheng Zhang1 insp.
Nicholas Z Lu1 insp.
Matthew T Sanchez1 insp.
Emilie Kahn1 insp.
Vioela J Caze1 insp.
Lequita M Mayhew1 insp.
That Q Dang1 insp.
Brittani N Franklin1 insp.
Christopher D Leach1 insp.
Michael E Maselli1 insp.
Christina A Miller1 insp.
John M Seale1 insp.
Denarvis C Mendenhall1 insp.
Karen E Masley-Joseph1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sage Products, LLC's 8 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