# FDA WARNING_LETTER - Clearwater Products, LLC - August 25, 2009

Source: https://www.keypedia.com/records/warning_letter/clearwater-products-llc/7cfd82c5-c51b-4109-ab49-32fe9233c4f6

> FDA WARNING_LETTER for Clearwater Products, LLC on August 25, 2009. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Clearwater Products, LLC
- Inspection Date: 2009-08-25
- Product Type: Devices
- Office Name: Florida District Office
- Summary: On March 10, 2010, the FDA issued a Warning Letter to Clearwater Products LLC, following an inspection from August 24-25, 2009. The inspection revealed that the firm's "Water Lily" colonic irrigation system is a misbranded and adulterated medical device.

Key violations include:
1.  **Misbranding (21 U.S.C. 352(t)(2)):** Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17).
2.  **Adulteration (21 U.S.C. 351(f)(1)(B)):** Lack of an approved Premarket Approval (PMA) application (21 U.S.C. 360e(a)) or an Investigational Device Exemption (IDE) (21 U.S.C. 360j(g)).
3.  **Misbranding (21 U.S.C. 352(o)):** Failure to notify the FDA of intent to introduce the device into commercial distribution (510(k) premarket notification) (21 U.S.C. 360(k)).
4.  **Misbranding (21 U.S.C. 352(o)):

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/salvatore-n-randazzo/c5f4bcc1-4880-4fb0-a932-c4823503dadf)
- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/clearwater-products-llc/7dea179d-008c-4f3d-a969-0f2cd53ebdec

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9