FDA investigators uncovered numerous quality system deficiencies during a December 2017 inspection of Laser Dental Innovations’ San Jose, California plant.

The firm was slapped with a Form 483 at the end of the inspection, but the FDA was not satisfied with the response, and issued a warning letter to the laser fiber optic surgical device manufacturer. 

Quality system failures ranged from inadequate corrective and preventive actions, failure to maintain complaint files, failure to establish procedures to control the design of devices, failure to ensure that all products received conform to requirements, and failure to establish procedures to ensure that device history records are maintained in accordance with the device master record.

The FDA inspector observed that the firm failed to document several CAPAs, and that records didn’t include a root cause analysis or investigation details. Moreover, no details were provided in the response to the 483 on how the problems would be remedied for complaints associated with broken or improperly functioning collets in the LiteSaber handpieces.

Design history files for the LifeSaber 10mm handpiece and StarLite Fiber Optic devices didn’t include records for design validation or design verification, and the company told the investigator that the records “did not exist.”

Laser Dental Innovations also failed to establish supplier contracts or supplier evaluations.