Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-02-23.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Feb 2018 – 23 Feb 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Oct 2015 – 13 Nov 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Nov 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2018
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Sayeeda Hdabe, Brenda Rivera
23 Feb 2018
21 CFR 820.75(c)
Documentation - review in response to changes or deviations
Cited by Sayeeda Hdabe, Brenda Rivera
23 Feb 2018
21 CFR 820.80(a)
Lack of or inadequate procedures - Acceptance activities
Cited by Sayeeda Hdabe, Brenda Rivera
23 Feb 2018
21 CFR 820.90(b)(2)
Product rework procedures, Lack of or inadequate procedures
Cited by Sayeeda Hdabe, Brenda Rivera
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 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chemence Medical Products, 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