Recent FDA Recall Highlights & Developments -
• The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
4/11/2019
/ Centers for Disease Control and Prevention (CDC) ,
Distributors ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Recalls ,
Manufacturer Liability ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Product Defects ,
Product Recalls
• Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations of other bulk substances that are...more
3/5/2019
/ Bulk Purchasing ,
DQSA ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Outsourcing Facilities ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more