The FDA smacked Bacterin International with two separate warning letters, knocking the company for alleged quality and other violations over manufacturing of a bone putty product and two kinds of wound drains.
Bacterin president and CEO Guy Cook told FierceMedicalDevices in a telephone interview that the company had worked to make improvements in the months following regulators' initial inspection of the company's Belgrade, MT, operations from July 16 to July 26, 2012. He observed that the FDA chose to issue the warning letters even as the company revised cited areas such as its medical device reporting procedures.
"We made the modifications and notified the FDA we were compliant," Cook told us. But "we respect the audit process. We embrace that. Audits are meant to make systems stronger and we will continue to work with the FDA to be in compliance and strengthen our internal systems."
COO Darrel Holmes added to FierceMedicalDevices that the company remains focused "on addressing all the facets of the warning letters at the same time," and is "working to present acceptable responses to the FDA in a timely manner in the schedule they outlined."
One letter cites the company for a number of quality system violations over how it manufactures its OsteoSelect Demineralized Matrix Bone Putty. Regulators say the company, in part, mislabeled one lot and took too long to address three other lots of putty that had endotoxin test results outside of specified standards. Additionally, the FDA knocked Bacterin for not having complaint files or a procedure to handle product complaints, and for lacking sufficient employee training.
The FDA also cited Bacterin for how it makes and promotes Elutia and Via-branded wound drains. Regulators say the company, for example, lacked a system to make sure its suppliers passed muster, and regulators said they couldn't determine if any of Bacterin's improvements over the summer were enough. The FDA also says the company needed better testing to make sure the wound drains met quality standards, and also a more effective way to address product complaints. Further, the FDA said the company made improper claims about its Elutia wound drain in promotional materials, such as claiming the drainage catheter could prevent infections.
With FDA warning letters, companies must notify regulators that they received the notices, are taking steps to address violations and also putting processes in place to prevent violations in the future.