Lack of Written Procedures Leads to Warning to Florida Company

Clearwater Products has received an FDA warning letter related to a lack of written procedures for its devices. The Port Richey, Fla., company, which manufactures the Water Lily colonic irrigation system, does not have written internal audit procedures and has not completed an internal audit, according to the March 10 warning letter. It also does not have written procedures for a final inspection of finished devices. Although the company documents the final inspection on a checklist, it discards the checklist after each device is shipped.
The GMP Letter