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

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Record Details

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)):

Company: Clearwater Products, LLC
Inspection Date: August 25, 2009
Product Type: Devices
Office: Florida District Office
People: Emma R. Singleton (District Director)
Salvatore N. Randazzo (Consumer Safety Officer)

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ID · 7cfd82c5-c51b-4109-ab49-32fe9233c4f6

Violation Codes10

21 U.S.C. 321(h)21 U.S.C. 352(t)(2)21 U.S.C. 360i21 CFR 80321 CFR 803.1721 U.S.C. 351(f)(1)(B)21 U.S.C. 360e(a)21 U.S.C. 360j(g)21 U.S.C. 352(o)21 U.S.C. 360(k)

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