Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-07-02.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jun 2015 – 2 Jul 2015 | Medical Devices & Rad Health | WL | On file |
| 3 Jun 2014 – 5 Jun 2014 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jun 2014
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Catherine J Laufmann
5 Jun 2014
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Catherine J Laufmann
5 Jun 2014
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Catherine J Laufmann
Investigators
FDA investigators tied to this site in the record.
Jocelyn C Turner1 insp.
Catherine J Laufmann1 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 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | 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 |
| 21 CFR 820.75(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 Dongguan Jianwei Electronics Products Co., Ltd.'s 2 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