FDA Warns German Device Firm Over Lack of Procedures
A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures.
At the time of the agency’s visit last May, the firm lacked documented design validation in the design history file — completed in July 2009 — for its Osbone Dental device. It also had failed to establish a procedure for the manufacturing of its IngeniOs HA-Synthetic Bone Particles, according to an FDA warning letter.
The firm’s July 2017 response to these GMP violations, first noted as Form 483 observations, described corrections such as revising documentation and personal training. But it did not specify whether the effectiveness of the corrective actions had been verified, and did not include reviews of all existing products and potential adverse events.
The FDA also flagged nonconformities in the firm’s complaint handling procedures. Curasan had failed to establish a requirement for evaluating complaints to determine whether they should be reported to the FDA under the medical device reporting regulations.
None of the 11 complaints that were reviewed by the FDA during the inspection had been evaluated for MDR reportability, and the firm also admitted to having no written MDR procedures.
The firm submitted an MDR procedure for review as part of its response to the 483. But the FDA deemed the identified corrective action to be inadequate. The procedure lacked definitions for certain key terms, specific calendar days to ensure timely submissions, and descriptions of documentation requirements.