CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Managing suppliers is critical, and your processes in doing so must be documented.
Document control is a critical part of your QMS.
There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
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.
No reviews of pre-market applications and no certificates to foreign governments signed—ouch!
Every company should understand the value of employing statistics to assist in running a business.
FDA appreciates nothing more than documented evidence of compliance.