FDA has expanded authority and regulatory power specifically for Adverse Events. FDA can now issue a Mandatory Recall if they determine that a cosmetic product is adulterated or that the exposure will cause serious adverse health consequences. They can also suspend a facility if there is reasonable probability of causing a serious adverse health consequence or public health concern. During inspections FDA can request information to help determine if the Adverse Events require a recall or to suspend a facility.
- Understanding new Adverse Event Requirements for Cosmetics
- Requirements for receiving adverse events and upcoming deadline for cosmetic labels
- Process and tips for implementation of an Adverse Event intake system
- Adverse Event Management Software Demonstration
