Market Overview

Registrar Corp Launches New Mock FDA Inspection Service


The Food Safety Modernization Act (FSMA) requires FDA to increase the number of Food Facility Inspections and to charge companies for re-inspection. Registrar Corp's new Food Safety Department conducts mock FDA Inspections to help companies prepare for FDA inspections.

Hampton, Virginia (PRWEB) February 28, 2013

Registrar Corp‘s Food Safety Department is in Europe, India, and Asia this week to conduct mock FDA inspections in advance of formal U.S. Food and Drug Administration (FDA) food facility inspections. The new Food Safety Modernization Act (FSMA) requires FDA to double the number of Food Facility Inspections each year for the next five years. Now nearly every facility that supplies food to the United States should expect an eventual FDA inspection.

In the past, FDA did not charge a fee to inspect (or re-inspect) a food facility. The FSMA amendments to the Food, Drug, and Cosmetic Act (FD&C Act), however, now authorize FDA to collect fees to cover 100% of the costs related to specific domestic and foreign food facility re-inspections. FDA announced their intent to collect these fees beginning in fiscal year 2012 via a Federal Register Notice issued on August 1, 2011.

The fee is to cover re-inspection related costs when an initial inspection, initiated on or after October 1, 2011, has identified violations “materially related to food safety requirements” of the FD&C Act. The re-inspection must be conducted specifically to determine whether compliance has been achieved.

FSMA requires FDA to charge food facilities re-inspection related costs on an hourly basis. Fees will be charged, without limit, for "whatever components" are deemed necessary per inspection "until the facility is again determined to be in compliance." (Federal Register, Vol. 77, No. 148, Page 45638). FDA re-inspection fees are as follows:

  • $221/hour if domestic travel is required
  • $289/hour if foreign travel is required.

The new risk of these high fees has many food facilities looking to third party auditors to perform mock FDA inspections for the purpose of reducing liability. With 19 offices worldwide, Registrar Corp is the largest of these FDA Regulatory Specialists. Registrar Corp assists companies with Registration, Labeling, and Food Safety Services.

As part of Registrar Corp's U.S. Agent service, Registrar Corp will dispatch a food safety expert from the United States to help facilities prepare if they receive a notice of FDA inspection with a specific inspection date. Registrar Corp's Food Safety Specialist will help identify potential food safety problems in the structure, processes, procedures and documentation used in your daily production. During the visit - typically two days (per facility) - the Food Safety Specialist will help staff to better understand FDA's expectations.

Registrar Corp also provides Mock FDA Inspections for food facilities that have not designated Registrar Corp as their U.S. Agent. For such food facilities, Registrar Corp provides the Mock FDA Inspection for a fee.

FSMA also requires that food and beverage manufacturers renew their U.S. FDA Food Facility Registration Renewal every even numbered year starting in 2012. The original deadline was set for December 31, 2012, but FDA extended the food facility registration renewal deadline to accommodate for a 22-day delay. FDA's food facility registration renewal deadline was pushed to January 31, 2013, with enforcement discretion. In addition, firms that failed to renew their food facility registration prior to the December 31, 2012 deadline (extended through enforcement discretion until January 31, 2013) may find their food shipments detained and their number invalid or cancelled in the coming months.    

For more information about the Food Safety Modernization Act (FSMA) or any FDA regulation, please contact Registrar Corp 24/7 at or call us at +1-757-224-0177. Additionally, Registrar Corp's nineteen global offices provide multilingual regulatory assistance to exporters.

About Registrar Corp: Registrar Corp assists companies with U.S. FDA regulations. Founded in 2003, the company has assisted more than 30,000 companies to comply with FDA requirements. With 19 global offices, Registrar Corp's team of multilingual Regulatory Specialists are available to assist you. For immediate assistance with U.S. FDA Regulations, phone Registrar Corp: +1-757-224-0177 or receive online Live Help from our regulatory specialists.

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