Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-26.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2026 – 26 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Feb 2018 – 5 Feb 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Jun 2015 – 2 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Apr 2012 | Not recorded | 483 | View 483 → |
| 2 Apr 2009 | Not recorded | 483 | View 483 → |
| 5 Dec 2002 | Not recorded | Clean | |
| 8 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2026
ISO 13485:2016 Clause 4.1.1
QMS not documented and maintained adequately
Cited by Ulysses D Singleton
26 Mar 2026
ISO 13485:2016 Clause 4.1.1
QMS not documented and maintained adequately
Cited by Ulysses D Singleton
26 Mar 2026
ISO 13485:2016 Clause 7.2.2
Review of requirements related to product not conducted
Cited by Ulysses D Singleton
Investigators
FDA investigators tied to this site in the record.
Ulysses D Singleton1 insp.
Richard K Vogel1 insp.
Lisa A Warner1 insp.
Ashley Segura1 insp.
Salvatore N Randazzo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.2.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.3.10 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Clearwater Colon Hydrotherapy, Inc.'s 5 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