Inovar Inc. received a Form 483 for failing to provide a product certification, evaluate complaints, and other observations.
Following an October 2016 visit to the company’s Logan, Utah, office, FDA inspectors observed that Inovar failed furnish to the dealer, at the time of delivery of a product, a certification that completed laser systems conformed to all applicable standards.
Specifically, the labeling applied to the systems did not include a statement of certification of conformance to performance standards. Inovar’s product engineer said Inovar does not provide any other form of certificate of conformance to the customer.
The Form 483 also said that not all complaints were reviewed and evaluated to determine whether an investigation was necessary.
The company’s procedures did not include requirements for evaluating each complaint to determine if an investigation was necessary or if the complaint needed to be reported to the FDA.
Twelve complaints reviewed did not have a justification for not investigating the issue or a medical device reporting determination.
In addition, customer complaints that were not required to be directly handled by Inovar but were provided as feedback are not recorded as complaints. Other than how these complaints were received, there was no documentation, including an investigation.
Inspectors also faulted documentation of corrective and preventive action (CAPA) procedures. CAPA records were closed after the due date and/or did not include an appropriate verification of effectiveness.
CAPAs also did not show a history of activity, especially between the implementation of corrective actions and verification of effectiveness. In addition, one of the thirteen device history records reviewed did not include completed verification steps and QA signatures for final release and distribution of the unit.
Lastly, the Form 483 said Inovar did not adequately establish procedures to control non-conforming products, procedures for device history records, and procedures to control environmental conditions.