Bard Hit With Warning Letter for Poor GMP

Devices made at a C.R. Bard facility in Puerto Rico do not conform with GMP requirements, and the company did not take complaints about defective products seriously enough, according to an FDA warning letter. In January and February 2005, the firm received about 61 complaints reporting leaflet fracture or tearing of the tricuspid valve in its Dual Port Wizard Low-Profile Replacement Gastronomy device. The company’s investigation found that its previous corrective and preventive actions had not fixed the problem, according to the letter.
The GMP Letter