Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-02-04.
At a glance
Inspections
5
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Feb 2016 – 4 Feb 2016 | Medical Devices & Rad Health | Clean | |
| 19 Feb 2015 – 2 Mar 2015 | Medical Devices & Rad Health | WL | On file |
| 14 May 2012 | Not recorded | 483 | View 483 → |
| 17 Jun 2010 | Not recorded | Clean | |
| 15 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2012
21 CFR 820.50(a)(1)
Evaluation and Selection, Suppliers, Contractors, etc.
Cited by Mary R Hole
Investigators
FDA investigators tied to this site in the record.
Jude C Dike1 insp.
Alla Dubrovsky1 insp.
Mary R Hole1 insp.
Maida Henesian1 insp.
Cntrctmntr Acton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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