Inspection of ambulatory surgical facilities that perform LASIK procedures is one of the options available to FDA to ensure that physicians and patients have current and accurate information to help them with their decisions about LASIK. These inspections allow FDA to identify reporting problems and provide opportunities to further educate user facilities about MDR reporting obligations.
A lot of pharmaceutical professionals have confusion between FDA Form 483 and Warning Letters. Both of these are issued by Food and Drug Administration (FDA) after a regulatory inspection of the manufacturing facility.
Definition of Day zero or consideration of Day Zero in cases where the Company uses third party call center to perform intake of complaints from the open channel for a toll free number, fax, Web email
Webinar - Complaint Handling - Best Practices Some regulatory inspectors interpret response as an action finding and not a simple acknowledgement of receipt. Are we seeing a trend in one direction?
Webinar - FDA Off-Label Promotion Guidelines