Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-11-18.
At a glance
Inspections
13
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Nov 2021 – 18 Nov 2021 | Human Drugs | WL | On file |
| 3 Apr 2019 – 10 Apr 2019 | Human Drugs | 483 | On file |
| 14 Nov 2017 – 21 Dec 2017 | Human Drugs | WL | On file |
| 22 Apr 2015 – 29 Apr 2015 | Human Drugs | 483 | On file |
| 28 Oct 2013 – 18 Nov 2013 | Human Drugs | 483 | On file |
| 27 Jul 2012 | Not recorded | 483 | On file |
| 30 Sep 2011 | Not recorded | 483 | On file |
| 9 Sep 2010 | Not recorded | Clean | |
| 11 Feb 2009 | Not recorded | 483 | View 483 → |
| 29 Aug 2007 | Not recorded | Clean | |
| 21 Jan 2005 | Not recorded | Clean | |
| 19 Feb 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Feb 2009
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.68(b)
Written record not kept of program and validation data
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.101(c)
Weighing/measuring/subdividing supervision
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
11 Feb 2009
21 CFR 211.192
Written record of investigation incomplete
Cited by Carolyn A Warren, Sandra Sejdinovic, Marie A Fadden
Investigators
FDA investigators tied to this site in the record.
April L Young3 insp.
Ross J Grigsby2 insp.
Anthony J Ladner2 insp.
Courtney R Tiegs2 insp.
Marie A Fadden2 insp.
Bei Y He1 insp.
Joseph A Piechocki1 insp.
Lauren E Merz1 insp.
Marissa S Henning1 insp.
Carolyn A Warren1 insp.
Sandra Sejdinovic1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fagron, Inc's 8 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