FDA Reinstates Sunland’s Registration…with Restrictions
The U.S. Food and Drug Administration (FDA) announced the reinstatement of Sunland Inc.’s registration with new requirements, imposed by U.S. District Judge William P. Johnson in a consent decree.
As the first food facility to have its registration suspended by the FDA, Sunland Inc. shut down its peanut butter facilities late September. FDA prohibited Sunland Inc. from “introducing product into interstate or intrastate commerce” after it linked Sunland Inc.’s food facilities to an outbreak of Salmonella Bredeney. The Food Safety Modernization Act (FSMA) grants FDA the authority to suspend a food facility’s registration.
FDA has now determined that Sunland’s food facility registration suspension is no longer necessary because “grounds no longer exist to continue the suspension actions.” FDA will reinstate Sunland’s food facility registration; however, there are restrictions still in effect.
Though its food facility registration is reinstated, Sunland Inc. cannot process or distribute food from its peanut butter plant or peanut mill plant in Portales, New Mexico until it has complied with all the requirements listed in the consent decree. FDA will verify compliance and will give Sunland Inc. written authorization to resume operations at both plants.
Judge Johnson’s consent decree requires Sunland to do follow many requirements including:
1. Implement a sanitation control program developed by an independent sanitation expert
2. Comply with FDA’s current Good Manufacturing Practices (cGMP) regulations
3. Conduct environmental monitoring and testing to ensure that disease-causing organisms are not present in the facility or in its finished foods and must have comprehensive inspections conducted by an independent sanitation expert.
Though it cannot process or distribute foods yet, Sunland Inc. is now able to receive, hold, and distribute raw, unshelled peanuts. FDA permits this because the peanuts will go to a processing facility that will eliminate Salmonella and other pathogenic bacteria.
Registrar Corp helps companies comply with FDA regulations. For more information about the Food and Beverage Regulations or any U.S. FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-244-0177.