Clearwater Colon Hydrotherapy, Inc
Form 483 issued March 26, 2026 · Ocala, Florida
- Inspection
- Mar 24 – Mar 26, 2026
- Investigator
- Ulysses D. Singleton
- Observations
- 6
- Pages
- 5
- FEI number
- 3000718678
In short: On March 26, 2026, FDA issued a Form 483 with 6 observations to Clearwater Colon Hydrotherapy, Inc in Ocala, Florida (FEI 3000718678) after an inspection that ran Mar 24 – Mar 26, 2026. The investigator was Ulysses D. Singleton.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 4.1.121 CFR 820
The quality management system was not documented in accordance…
- 02ISO 13485:2016 Clause 7.5.6
Records of the results and conclusion of validation of processes and necessary actions from the…
- 03ISO 13485:2016 Clause 7.3.10
A design and development file does not adequately include or reference records generated to demonstrate conformity…
- 04ISO 13485:2016 Clause 7.2.2
Review of the requirements related to product was not conducted prior to committing to supply…
This inspection in context
Ulysses D. Singleton
2 documents · 2024–2026
Cites 820 more than any other section. Most of their documents are for sites in Florida.
The firmClearwater Colon Hydrotherapy, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Clearwater Colon Hydrotherapy, Inc?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Clearwater Colon Hydrotherapy, Inc?
Ulysses D. Singleton is named on this Form 483, for the inspection of Mar 24 – Mar 26, 2026. Each investigator has a profile showing what they cite most.
When was Clearwater Colon Hydrotherapy, Inc inspected by FDA?
The inspection ran Mar 24 – Mar 26, 2026, and the Form 483 is dated March 26, 2026.
How do I get the full Form 483 for Clearwater Colon Hydrotherapy, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.