Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-23.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Feb 2023 – 23 Feb 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Jun 2019 – 6 Jun 2019 | Medical Devices & Rad Health | Clean | |
| 28 Aug 2017 – 31 Aug 2017 | Medical Devices & Rad Health | WL | View 483 → |
| 23 Mar 2015 – 26 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Jun 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Aug 2017
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by James M Simpson
Investigators
FDA investigators tied to this site in the record.
Alexandria L Capuano1 insp.
Babatunde D Babalola1 insp.
James M Simpson1 insp.
Janet Pulver1 insp.
Dawn M Braswell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1002.20(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1020.30(h)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Dexcowin Co. Ltd.'s 4 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