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The U.S. Food and Drug Administration (FDA) recently suspended the food facility registration of SM Fish Corp, located in Far Rockaway, NY, following a failed re-inspection and re-sampling of their ready–to-eat (RTE) seafood products. An initial inspection of the facility from June 14, 2016 to July 6, 2016 revealed that several environmental samples tested positive for Listeria. FDA requested that SM Fish Corp. recall some of its RTE products and shut down briefly to revise its cleaning and sanitation procedures, to which the facility agreed.

Following the initial inspection SCORE, a decision making body of individuals intended to ”ensure the agency engages in an integrated approach to identifying timely and efficient measures in order to help mitigate public health risks,” requested a re-inspection of SM Fish Corp. in order to ensure the problems found at the facility were resolved.

The decision to suspend the facility’s registration was made under the authority of the 2011 Food Safety Modernization Act (FMSA) after FDA’s re-inspection in August 2016 revealed a continued widespread Listeria contamination within the facility. As a result of this suspension, SM Fish Corp. is banned from marketing food in the United States. FDA may lift the suspension only when the agency determines the facility’s food no longer has reasonable probability of posing serious health issues or death to human consumers.

Facilities are often unaware of the cost and time associated with FDA re-inspections. When FDA initially inspects a food facility, it is financed by the agency, but if FDA finds reason to re-inspect, the agency may charge re-inspections fees. For facility re-inspection fees, FDA will invoice the responsible party for the direct hours; including time spent preparing and traveling, at the appropriate hourly rate. The FY 2017 hourly rates for FDA re-inspections are as follows:

  • $221 per hour for domestic facilities
  • $285 per hour when foreign travel is required

It is crucial to prepare for possible FDA inspections in order to prevent costly re-inspections that may lead to the suspension of your food facility registration. Registrar Corp can assist facilities preparing for FDA inspections. A Food Safety Specialist can perform mock FDA inspections  at the request of both foreign and domestic facilities to help identify any potential problems and help facilities to better understand FDA’s expectations. Additionally, if your foreign food facility utilizes Registrar Corp as its U.S. Agent, Registrar Corp will perform a mock inspection free of charge (other than travel and lodging expenses) when FDA issues a Notice of Inspection for that facility.

For more information or assistance regarding FDA inspections, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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