Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-01-26.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jan 2016 – 26 Jan 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Feb 2013 | Not recorded | 483 | View 483 → |
| 22 Oct 2010 | Not recorded | Clean | |
| 27 Dec 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jan 2016
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Debara R Reese
Investigators
FDA investigators tied to this site in the record.
Patrick B Cummings2 insp.
Debara R Reese1 insp.
Robert M Barbosa1 insp.
James A Lane1 insp.
Kimberly Y Martin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Morris Innovative, Inc.'s 2 Form 483s
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