If a device establishment is going to invest significant time and money into building a cleanroom or a controlled environment room, it makes zero sense not to perform proper monitoring of the environment.
Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.
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.