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 FDA said its inspection showed that C.R. Bard’s in-process controls are frequently ineffective. The agency also faulted the company’s process for identifying nonconforming products and preventing their distribution to the market.

“Your firm has repeatedly distributed products that were mislabeled, and it seems that you do not appreciate the criticality of your mislabeling issues,” the FDA’s letter stated. “This is evidenced by your failure to take appropriate action with respect to distributed products that you confirmed were mislabeled after investigating complaints that you received regarding the products. We find your lack of action highly objectionable because your mislabeled products do not have the identity that they represent to possess. We also find your medical evaluations related to these incidents are inadequate because you rely on the user to identify that the wrong device has been supplied.”

The FDA also reprimanded Bard for failing to extend investigations and corrective actions to its distributed products. And, it expressed concern over the “large number” of complaints about the company’s Dual Port Wizard Low Profile Replacement Gastronomy product.

“It appears that you have been unable to determine the root cause for the leaflet fracture defect that has been consistently reported in the many consumer complaints received by your firm,” the FDA said. “We acknowledge that much of your production is destined for the market in Japan, but you are also distributing this product on the United States market.”

The FDA recommended that Bard conduct a more thorough assessment of the manufacturing process to identify the root cause of the fracture and implement “appropriate corrective and preventive actions.”

The warning letter is accessible at: http://www.fda.gov/foi/warning_letters/s6944c.htm.

SOURCE: Staff and wire reports