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FDA/USDA Regulated Industries

The Federal Food & Drug Administration (FDA) and the United States Department of Agriculture (USDA), were created in order to ensure that food, beverages, meats, poultry, fish, dairy products, drugs and medical devices are consistently produced at a high quality level and safely delivered to the populace.

The FDA is responsible for ensuring that foods are safe, wholesome and sanitary, that human and veterinary drugs, biological products and medical devices are safe and effective, that cosmetics are safe, and that electronic products that emit radiation are safe.

The USDA has the responsibility of ensuring agriculturally produced foods, meats, poultry and egg product safety by implementing steps to reduce the prevalence of food-borne hazards from farm to table.   

A critical part of the responsibilities of these agencies is to develop, implement and police current good manufacturing practices (cGMP) standards.  This involves accountability and documentation at all levels of the manufacturing process from engineering of manufacturing facilities, handling and approval of raw materials, operation of the manufacturing processes and packaging and delivery to the final users.  Both agencies have the power of product rejection and recall based on well defined quality standards.  In many ways both agencies work cooperatively to ensure the common health.

Pennoni Associates, in partnership with industry experts, provides the engineering and process expertise to assist facilities in addressing and consistently meeting the stringent requirements of these agencies. Our areas of focus include, but are not limited to:

  • Drugs and Biologics
  • Medical Devices
  • Food and Beverage