Oct 1, 2013 | Foods, FSMA Perspective
Reporting requirements from third-party audits drew many questions from stakeholders at the agency’s public meeting on proposed rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies, held in...
Oct 1, 2013 | Issue of the Month, Medical Devices
By EAS Senior Consultant Paul F. Tilton Do you know when a product enhancement is considered to be a recall in the eyes of the Food and Drug Administration? If not, I draw your attention to the draft guidance from FDA entitled Distinguishing Medical Device Recalls...