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.
Failure to investigate complaints is a major compliance failure.
When device modifications could affect safety and effectiveness, a premarket notification submission is required.
The design history file establishes the baseline for the design and development of a device.
Don’t overlook this critical practice.
Denying the agency to inspect your facility is a violation.