On March 11, 2022, the U.S. Food and Drug Administration (FDA) issued guidance on its intent not to enforce certain provisions of five rules that implement the FDA Food Safety Modernization Act (FSMA).

The enforcement discretion policies announced are specific to provisions in the following rules:

  • Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food.
  • Foreign Supplier Verification Program (FSVP).
  •  Produce Safety (PSR).
  • Intentional Adulteration (IA).

These guidelines are based on which previously announced enforcement policies?

  •  Extension of Enforcement Discretion Policy for Supply-Chain Program Requirements Applicable to Contract Manufacturers of Human and Animal Food
  •  Enforcement Policy for Certain Entities and Requirements under the Intentional Adulteration Rule
  •  Enforcement Discretion for facilities that conduct farm-related activities
  • Enforcement Discretion for the reanalysis provisions in the IA rule in certain circumstances
  •  Enforcement Policy for Supplier Approval and Verification Requirements in the PC Human, PC Animal and FSVP Regulations

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About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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