Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-02-15.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2018 – 15 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 26 Jan 2015 – 29 Jan 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Feb 2012 | Not recorded | 483 | On file |
| 12 Aug 2010 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jan 2015
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Leighton K Ngai
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 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Innovative Medical Manufacturing Co.'s 3 Form 483s
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