Overview
- 11 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-11.
At a glance
Inspections
11
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2025 – 11 Feb 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Sep 2021 – 10 Sep 2021 | Medical Devices & Rad Health | 483 | On file |
| 16 Sep 2019 – 20 Sep 2019 | Medical Devices & Rad Health | 483 | On file |
| 6 Mar 2017 – 23 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Feb 2016 – 17 Mar 2016 | Medical Devices & Rad Health | WL | View 483 → |
| 13 Aug 2013 – 21 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jun 2012 | Not recorded | 483 | On file |
| 27 Jul 2010 | Not recorded | 483 | View 483 → |
| 12 Dec 2008 | Not recorded | Clean | |
| 8 Mar 2007 | Not recorded | Clean | |
| 27 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Mar 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Lisa A Warner, Stanley B Eugene, Kimberly Lewandowski-Walker
23 Mar 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Lisa A Warner, Stanley B Eugene, Kimberly Lewandowski-Walker
23 Mar 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Lisa A Warner, Stanley B Eugene, Kimberly Lewandowski-Walker
Investigators
FDA investigators tied to this site in the record.
Leo J Lagrotte3 insp.
Monica C Burgos Garcia2 insp.
Lisa A Warner2 insp.
Suzanne M Healy1 insp.
Sean T Creighton1 insp.
Emma R Schaefer1 insp.
Stanley B Eugene1 insp.
Kimberly Lewandowski-Walker1 insp.
Bill Tackett1 insp.
Michael H Tollon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1010.2(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.10(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Oscor Inc.'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