• FSMA established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit


Continue Reading FDA Issues Temporary Policy Regarding Certain Accredited Third-Party Certification Program Requirements During COVID-19

 

  • We reported on the Food and Drug Administration’s (FDA) November 2017 guidance giving certain co-manufacturers two more years to comply with requirements for a supply-chain program for certain raw materials


Continue Reading FDA Will Extend Enforcement Policy Allowing Some “Co-Manufacturers” Additional Time to Implement Certain FSMA Supply-Chain Program Requirements

 

  • As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive


Continue Reading FDA Releases Chapter 14: Recall Plans in the Latest Installment to the Agency’s Multi-Chapter Draft Guidance on the Human HARPC Rule