Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2014-11-24.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2014 – 24 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 9 Jan 2012 | Not recorded | 483 | View 483 → |
| 5 Nov 2009 | Not recorded | Clean | |
| 12 Jun 2009 | Not recorded | Clean | |
| 13 Jun 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jan 2012
21 CFR 803.17(a)(2)
Lack of System for Determining MDR Events
Cited by Sergio Chavez, David Dar
9 Jan 2012
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Sergio Chavez, David Dar
9 Jan 2012
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Sergio Chavez, David Dar
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 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Celera Corporation's 1 Form 483
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