Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-02-10.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jan 2016 – 10 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jun 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2016
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by James P Finn, Tamara S Rosbury
10 Feb 2016
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by James P Finn, Tamara S Rosbury
10 Feb 2016
21 CFR 820.70(i)
Documentation of software validation
Cited by James P Finn, Tamara S Rosbury
10 Feb 2016
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by James P Finn, Tamara S Rosbury
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 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cellay, 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