It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
When it comes to compliance, the FDA does not grant special dispensation.
Yes, there is a link between Form 483 observations and failing to conduct management reviews.
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.