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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

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: Salvatore N. Randazzo (Consumer Safety Officer)
Emma R. Singleton (District Director)

Open in Dashboard

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

Violation Codes10

21 CFR 820.2221 U.S.C. 360j(g)21 U.S.C. 352(t)(2)21 U.S.C. 36021 U.S.C. 351(f)(1)(B)21 CFR 820.100(a)21 CFR 82021 U.S.C. 321(h)21 U.S.C. 360(k)21 U.S.C. 360e(a)

Full citation text and observation details available on the Dashboard.