Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-11.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2022 – 11 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Aug 2018 – 9 Aug 2018 | Medical Devices & Rad Health | Clean | |
| 2 May 2017 – 4 May 2017 | Medical Devices & Rad Health | Clean | |
| 7 Dec 2015 – 10 Dec 2015 | Medical Devices & Rad Health | Clean | |
| 13 Oct 2014 – 16 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Sep 2013 – 6 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Mar 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Nov 2022
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Thai T Duong
Investigators
FDA investigators tied to this site in the record.
Kwong P Lee2 insp.
Thai T Duong1 insp.
Janet B Abt1 insp.
Stephen C Smith1 insp.
Sergio Chavez1 insp.
Edward J Janik1 insp.
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 | 2x |
| 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 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PLEXUS Manufacturing Sdn. Bhd.'s 4 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