Overview
- 11 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
11
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 20 Sep 2024 | Human Drugs | 483 | View 483 → |
| 20 Jul 2021 – 18 Aug 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Jul 2019 – 15 Aug 2019 | Human Drugs | 483 | View 483 → |
| 22 Oct 2018 – 24 Oct 2018 | Medical Devices & Rad Health | 483 | On file |
| 15 Sep 2017 – 20 Sep 2017 | Human Drugs | 483 | On file |
| 31 Oct 2016 – 4 Nov 2016 | Human Drugs | 483 | View 483 → |
| 7 Oct 2014 – 10 Oct 2014 | Human Drugs | 483 | View 483 → |
| 19 Sep 2012 | Not recorded | 483 | View 483 → |
| 22 Sep 2010 | Not recorded | Clean | |
| 26 Mar 2010 | Not recorded | 483 | View 483 → |
| 31 Jan 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Aug 2021
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Frank J Marciniak, Adetutu M Gidado
18 Aug 2021
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Frank J Marciniak, Adetutu M Gidado
18 Aug 2021
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Frank J Marciniak, Adetutu M Gidado
Investigators
FDA investigators tied to this site in the record.
Helen Verdel3 insp.
Frank J Marciniak2 insp.
Susan O Oladeji1 insp.
Adetutu M Gidado1 insp.
Emmanuel J Ramos1 insp.
MDSAP harperd1 insp.
Melissa T Roy1 insp.
Jessica M Monteiro1 insp.
Dhaval H Patel1 insp.
Meredith L Sheridan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Water-Jel Technologies, LLC's 9 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