Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-03-31.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Mar 2016 – 31 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Mar 2016
21 CFR 806.20(a)
Records not kept
Cited by Bonnie E Conley, Markeesa M Scales, Bonnie E Pierson
31 Mar 2016
21 CFR 806.20(a)
Records not kept
Cited by Bonnie E Conley, Markeesa M Scales, Bonnie E Pierson
31 Mar 2016
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Bonnie E Conley, Markeesa M Scales, Bonnie E Pierson
31 Mar 2016
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Bonnie E Conley, Markeesa M Scales, Bonnie E Pierson
31 Mar 2016
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Bonnie E Conley, Markeesa M Scales, Bonnie E Pierson
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 806.20(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind InvisionHeart, Inc.'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