Device establishments must maintain records of acceptable suppliers.
If an activity is not documented, it did not happen.
Although not always subject to receiving inspection, defining control of non-inventory items, such as manufacturing materials, is critical.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.
This offending company has “significant” violations regarding reporting corrections and removals to FDA.
If your firm does not have an MDR procedure, FDA will find out.
Documentation proves compliance, including when it comes to acceptance activities.
Failure to investigate complaints is a major compliance failure.
Although not as stringently controlled as medical devices, veterinary devices fall under FDA’s authority. And the agency is watching.
When device modifications could affect safety and effectiveness, a premarket notification submission is required.