The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?
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.
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.