Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-11.
At a glance
Inspections
11
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Aug 2017 – 11 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 21 Oct 2015 – 28 Oct 2015 | Medical Devices & Rad Health | Clean | |
| 22 Oct 2013 – 15 Nov 2013 | Medical Devices & Rad Health | 483 | On file |
| 21 Jun 2012 | Not recorded | 483 | On file |
| 1 Dec 2011 | Not recorded | Clean | |
| 17 Dec 2010 | Not recorded | 483 | View 483 → |
| 16 Jun 2010 | Not recorded | Clean | |
| 28 Sep 2009 | Not recorded | 483 | On file |
| 18 Jan 2008 | Not recorded | 483 | On file |
| 4 Aug 2005 | Not recorded | Clean | |
| 4 Oct 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Dec 2010
21 CFR 803.50(a)(2)
Report of Malfunction
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 803.52(b)(1)
Adverse Event of Product Problem
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 803.52(f)(1)
Type of Reportable Event
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 820.30(f)
Design verification - documentation
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
Investigators
FDA investigators tied to this site in the record.
Jocelyn E Massey3 insp.
Jennifer M Gogley2 insp.
Sonya L Karsik2 insp.
James R Fleckenstein2 insp.
MDSAP harperd1 insp.
Dejon N Harris1 insp.
Cntrctmntr Anderson1 insp.
Donna L Besone1 insp.
Scott K Zika1 insp.
Karen L Bauer1 insp.
Leonard H Lavi1 insp.
Juanita Banuelos1 insp.
Michael D Kawalek1 insp.
Norman Wong1 insp.
Mei-Chen Mu1 insp.
Vickie L Anderson1 insp.
Deborah A Greco1 insp.
Trudy R Papson1 insp.
Selene T Torres1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Sterilization Products' 5 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