Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-01-29.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2014 – 29 Jan 2014 | Human Drugs | 483 | View 483 → |
| 22 Aug 2011 | Not recorded | 483 | View 483 → |
| 30 Sep 2010 | Not recorded | 483 | View 483 → |
| 10 Nov 2009 | Not recorded | 483 | On file |
| 1 Feb 2007 | Not recorded | Clean | |
| 18 Aug 2005 | Not recorded | Clean | |
| 30 Sep 2003 | Not recorded | Clean | |
| 8 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Aug 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Debra I Love, Denarvis C Mendenhall
22 Aug 2011
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Debra I Love, Denarvis C Mendenhall
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 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind H2O Plus, LLC'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