U.S. FDA has recently advised that it intends to inspect foreign food facilities located in Argentina during the period of February 4th to March 5, 2012.
Food facilities targeted for a U.S. FDA inspection are provided written notice via email. The foreign food facilities’ U.S. Agents, as designated in the food facility registration module (FFRM), are simultaneously provided notice as well.
The food facility’s inspection is typically conducted by one or more investigators from the U.S. FDA to determine if the facility is operating in accordance with the Food, Drug, and Cosmetic Act, regulations set forth in Title 21 of the U.S. Code of Federal Regulations that are applicable to the products being produced, and other laws U.S. FDA enforces. U.S. FDA will conduct the inspection at the food facility during normal operating hours when responsible personnel are available to provide U.S. FDA with adequate information about the operations and access to the processing and production records. They expect that the food facility will be operating during the inspection so that their investigators can observe production activities.
After responding to the notice of inspection, U.S. FDA will contact the firm again to request their assistance in identifying the nearest airport, hotels, and transportation. If it is not possible for the facility to accommodate the inspection on the dates U.S. FDA proposes, then the firm must respond in writing as to why the date and time are not reasonable and must propose a suitable date and time for the inspection.
For questions related to U.S. FDA Foreign Food Facility inspections or any U.S. FDA regulation, please contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.