Anneke Baran Altieri

Jan 13, 2025 | jdsupra.com | Anneke Baran Altieri |Maile Gradison

On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.1 Although this document is not part of the multi-chapter Preventive Controls for Human Food (PCHF) rule (21 CFR Part 117) guidance series, it is must-read material for manufacturers of low-moisture ready-to-eat (LMRTE) human foods that are covered...

Mar 19, 2024 | jdsupra.com | Anneke Baran Altieri |Andrea Bruce |Elizabeth Fawell

The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance), which includes the highly anticipated revised draft of Appendix 1: Known or Reasonably Foreseeable Hazards (“Potential Hazards”), along with a revised draft Introduction.1 The revised draft Introduction and Appendix 1 reflect comments and feedback FDA received on...

Mar 18, 2024 | lexology.com | Elizabeth Fawell |Maile Gradison Hermida |Andrea Bruce |Anneke Baran Altieri

The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance), which includes the highly anticipated revised draft of Appendix 1: Known or Reasonably Foreseeable Hazards (“Potential Hazards”), along with a revised draft Introduction.1 The revised draft Introduction and Appendix 1 reflect comments and feedback FDA received on...