The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
Training is not a nice-to-have; it’s a fundamental requirement.
You must respond within 15 days, and you must show FDA how your establishment will be brought back to compliance.
The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.
Failing to report serious patient injuries will win you a warning letter.
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.