Overview
- 11 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-17.
At a glance
Inspections
11
Form 483s
10
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Oct 2025 – 17 Oct 2025 | Human Drugs | 483 | On file |
| 8 Mar 2021 – 19 Mar 2021 | Human Drugs | 483 | View 483 → |
| 3 Sep 2019 – 6 Sep 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Apr 2019 – 19 Apr 2019 | Human Drugs | 483 | View 483 → |
| 8 May 2017 – 17 May 2017 | Human Drugs | WL | View 483 → |
| 20 Oct 2015 – 2 Nov 2015 | Human Drugs | WL | View 483 → |
| 24 Oct 2011 | Not recorded | 483 | View 483 → |
| 4 May 2011 | Not recorded | 483 | On file |
| 5 Nov 2010 | Not recorded | 483 | View 483 → |
| 4 Mar 2008 | Not recorded | 483 | On file |
| 27 Aug 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Scientifically sound laboratory controls
Cited by Uttaniti Limchumroon, Lisa Shin
Extent of discrepancy, failure investigations
Cited by Uttaniti Limchumroon, Lisa Shin
Complete test data included in records
Cited by Uttaniti Limchumroon, Lisa Shin
Approve or reject procedures or specs
Cited by Uttaniti Limchumroon, Lisa Shin
Pkg / Labeling Operations Area
Cited by Uttaniti Limchumroon, Lisa Shin
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 211.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Diamond Wipes International, Inc.'s 10 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