Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-08-30.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Aug 2017 – 30 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Mar 2013 – 22 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 13 Jul 2010 | Not recorded | Clean | |
| 15 Jul 2008 | Not recorded | Clean | |
| 27 Apr 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2017
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Karen M Rodriguez
30 Aug 2017
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Karen M Rodriguez
30 Aug 2017
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Karen M Rodriguez
30 Aug 2017
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Karen M Rodriguez
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 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Avazzia, Inc's 1 Form 483
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