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Associate vCard
  • ST&R
Independent FDA Regulatory and Strategic Consultant vCard
  • ST&R

Related Services

FSMA Compliance Services

The Food Safety Modernization Act requires certain controls to be in place all along the food supply chain, from
harvest or processing to transportation, importation, sale and distribution in the U.S.

Failure to comply with FSMA requirements can result in suspension of food facility registration, withdrawal of
commercial contracts with major retail grocery and food service customers, disruption of consumer confidence,
placement on FDA import alerts, product recall, and financial loss.  

ST&R’s FDA Practice Group professionals are experts in all aspects of compliance with the FSMA. Our staff includes former high-ranking FDA officials involved in the development and implementation of the FSMA; attorneys with advanced degrees in food science and state-of-the-art scientific training in microbiology, toxicology, food packaging and food engineering; and international trade attorneys and advisors experienced in representing clients at all stages of the food supply chain. STR professionals can:

  • review and analyze quality assurance and quality control programs and help correct documentation deficiencies
  • conduct on-site facility inspections and determine compliance
  • determine and allocate responsibilities of supply chain partners
  • review, draft and finalize food safety plans
  • continuing guarantees from upstream and downstream suppliers
  • review vendor agreements and indemnification issues
  • review product liability and contamination and recall insurance coverage
  • prepare documentation for Foreign Supplier Verification Program and Voluntary Qualified Importer Program
  • work with government agencies to address border delays
  • develop structured liability assignment agreements
  • serve as FSMA-required qualified individual
  • conduct in-house training of compliance personnel and import/export staff
  • prevent and/or remove from import alerts
  • provide guidance on appropriate and cost-effective use of third-party certification
  • determine compliance with FDA’s filer evaluation program
  • USDA compliance for poultry and meat industries
  • audit opinion verifications
T: 305-894-1043
Associate
  • ST&R
T: 202-734-3939
Independent FDA Regulatory and Strategic Consultant
  • ST&R

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