Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Apr 2026 – 9 Apr 2026 | Medical Devices & Rad Health | Clean | |
| 24 Jul 2023 – 27 Jul 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Nov 2019 – 7 Nov 2019 | Medical Devices & Rad Health | Clean | |
| 6 Mar 2017 – 9 Mar 2017 | Medical Devices & Rad Health | Clean | |
| 3 Nov 2011 | Not recorded | Clean | |
| 20 Jan 2011 | Not recorded | WL | View 483 → |
| 24 Oct 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jul 2023
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Brittani N Franklin
27 Jul 2023
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Brittani N Franklin
Investigators
FDA investigators tied to this site in the record.
Dawn M Braswell1 insp.
Brittani N Franklin1 insp.
Joey C West1 insp.
Laiza V Garcia1 insp.
Perry H Gambrell1 insp.
Stephen D Eich1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | 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(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Innolatex Sdn. Bhd.'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