Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-07-20.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2016 – 20 Jul 2016 | Medical Devices & Rad Health | Clean | |
| 17 Aug 2015 – 29 Sep 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Jul 2014 – 21 Aug 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 May 2012 | Not recorded | 483 | View 483 → |
| 8 Jan 2010 | Not recorded | 483 | View 483 → |
| 12 Apr 2006 | Not recorded | Clean | |
| 17 Oct 2003 | Not recorded | Clean | |
| 11 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2015
21 CFR 820.198(c)
Investigation of device failures
Cited by Frank J Marciniak, Xiaoping Guan
29 Sep 2015
21 CFR 820.198(c)
Investigation of device failures
Cited by Frank J Marciniak, Xiaoping Guan
29 Sep 2015
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Frank J Marciniak, Xiaoping Guan
29 Sep 2015
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Frank J Marciniak, Xiaoping Guan
29 Sep 2015
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Frank J Marciniak, Xiaoping Guan
Investigators
FDA investigators tied to this site in the record.
Frank J Marciniak2 insp.
Xiaoping Guan2 insp.
Eric J Cunningham1 insp.
Dhaval H Patel1 insp.
Amy M Cramer1 insp.
Nicholas A Violand1 insp.
Barbara J Wilimczyk-Macri1 insp.
Addam S Reynolds1 insp.
Kinh Q Mac1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Excelsior Medical LLC's 4 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