Comprehensive Food Safety & Regulatory Solutions

Helping food manufacturers and businesses navigate complex regulatory requirements, strengthen food safety systems, and improve operational performance.
Our specialized services combine scientific expertise, regulatory guidance, and practical solutions to address the unique challenges of the food industry.

Expert Solutions for Every Food Safety Challenge

At International Safe Food Design and Compliance LLC, we provide specialized consulting services to help organizations manage food safety risks and meet regulatory requirements.

From food process design and FDA filing support to microbiological investigations and operational training, our services are designed to address critical challenges across the food industry.

We work closely with our clients to understand their needs and develop practical, science-based solutions that support safer products and stronger food safety systems.

Formula & Food Process Safety Design

Developing safe and effective food formulations and processes are essential to producing quality products and maintaining consumer safety and regulatory compliance.

ISFDAC provides specialized guidance on food formulation and process safety, helping manufacturers evaluate their products and processes and address relevant food safety considerations.

Our support includes:

  • Food formulation and process safety guidance

  • Support in designing formulations, processes, and packaging that meet optimized and efficient production line needs. 

  • Thermal processing, Product Safety, and working with appropriate regulatory classifications.

  • Support in developing safe products that meet both closed and opened shelf life needs, whether refrigerated – RTE –  or commericially sterile ambient shelf stable foods. 

FDA LACF / Acidified Filing Support

Acidified and LACF are subject to the regulations of FDA 21 CFR Part 108, 113, 114, and USDA 9 CFR Part 431.  Understanding these requirements is important for manufacturers seeking to maintain compliant operations, and particulalry, for importers regarding Foreign Supplier Requirments.

ISFDAC provides technical and regulatory support to help businesses navigate applicable FDA / USDA Filing requirements for these products.

Our Process Authority support includes:

  • Process Authority Process Development and PA Letters for Filing with FDA

  • Acidified and LACF SID Filing Assistance

  • Process Deviation Evaluation and Dispositions

  • Training and Documentation support

Import/Export & Foreign Supplier Verification Support

International food trade involves regulatory requirements and supplier verification responsibilities to assure product safety to the same standards as local production. Businesses need to manage these requirements and support food safety throughout their supply chains.

ISFDAC helps organizations understand relevant import compliance obligations and develop appropriate FDA and USDA foreign supplier verification practices, as well as, meeting Export Requirements of of other countries.

Our support includes:

  • Foreign Supplier Verification Program (FSVP) guidance

  • Assist in eliminating gaps in food safety documentation pertaining to foreign suppliers

  • Onsite inspection and audits of foreign facilities using highest industry standards to ensure product safety is achieved by deisgn and processes are validated. 

Microbiological Incident Investigation & Remediation

Microbiological contamination incidents can create serious challenges for food businesses. A FSMA Based Root Cause Analysis and structured investigation helps organizations understand potential contamination sources and determine appropriate corrective actions.

ISFDAC provides World Class Expertise and specialized technical support to help businesses investigate microbiological incidents and develop practical remediation strategies and  solid exculpatory support..

Our support includes:

  • Microbiological incident investigation

  • Contamination source assessment

  • Root cause investigation support

  • Remediation and corrective action guidance

Industry Expertise

Every food industry sector has distinct operational, technical, and regulatory challenges. ISFDAC provides specialized consulting tailored to the needs of different food businesses.

Our multidisciplinary expertise helps organizations address food safety challenges while considering their products, processes, and operational requirements.

Our industry experience includes:

  • Dairy and Ice Cream:  Listeria monocytogenes: (World Class Expertise worked with largest Ice Cream Company globally).  Was first to introduce and develop Environmental Mapping based on Genotypes for Root Cause Analaysis, Harborage, and Resident strains).

  • Processed, Fresh, RTE, Beverages, Global Tea Expert

  • Acidified and low-acid foods: Process Authority

  • Aseptic and ESL processing

  • Dressings, sauces, and spreads

Our support includes:

  • Industry-specific food safety consulting

  • Technical and regulatory guidance

  • Food process and operational assessments

  • Tailored solutions for business requirements

Good Agricultural Practices & Produce Safety

Food safety begins at the agricultural level. Good Agricultural Practices (GAP) and appropriate produce safety measures help businesses manage potential risks during growing, harvesting, handling, and distribution.

ISFDAC provides guidance to help agricultural businesses strengthen their food safety practices and address applicable produce safety requirements.

Our support includes:

  • Good Agricultural Practices guidance

  • Produce safety program support

  • Agricultural food safety risk assessment

  • Guidance on applicable produce safety requirements

Food Safety Culture, R&D & Operational Training

A strong food safety culture requires knowledgeable employees, effective procedures, and continuous improvement. Research and development also play an important role in creating safe and reliable food products.

ISFDAC supports organizations in strengthening food safety awareness, improving operational practices, and addressing product development challenges.

Our support includes:

  • Food safety culture development

  • Employee and operational training

  • Research and development support

  • Food safety awareness and continuous improvement