Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-07-15.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jul 2016 – 15 Jul 2016 | Human Drugs | 483 | View 483 → |
| 20 Aug 2015 – 1 Sep 2015 | Human Drugs | 483 | View 483 → |
| 20 Aug 2015 – 28 Aug 2015 | Human Drugs | Clean | |
| 9 Jun 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2016
21 CFR 58.185(a)(10)
Final report: names of those involved
Cited by Carmen Y Fisher, Abhijit Raha
15 Jul 2016
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Carmen Y Fisher, Abhijit Raha
15 Jul 2016
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Carmen Y Fisher, Abhijit Raha
15 Jul 2016
21 CFR 58.185(a)(10)
Final report: names of those involved
Cited by Carmen Y Fisher, Abhijit Raha
Investigators
FDA investigators tied to this site in the record.
Vickie J Kanion2 insp.
Lisa D Ellis2 insp.
Carmen Y Fisher1 insp.
Abhijit Raha1 insp.
Jessica L Peterson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.29(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Xenometrics, LLC's 2 Form 483s
Source PDFs 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