Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-02-26.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2014 – 26 Feb 2014 | Biologics | Clean | |
| 9 Mar 2012 | Not recorded | 483 | View 483 → |
| 17 Sep 2009 | Not recorded | 483 | View 483 → |
| 16 Aug 2006 | Not recorded | Clean | |
| 18 May 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Mar 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Barbara A Rusin
9 Mar 2012
21 CFR 606.100(b)(15)
Schedules and procedures for equipment & calibration
Cited by Barbara A Rusin
17 Sep 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Sherri J Jackson, Catherine V Quinlan
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Huron Medical Center's 2 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