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
November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality...more
• FDA has announced new quality metrics pilot programs that seek industry stakeholder perspective and feedback.
• FDA’s voluntary pilot programs target companies submitting Type C and Pre-ANDA meeting requests, as well as...more
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