PFSS
Honolulu, HI USA
808.725.8008
info@pacfss.com
PACIFIC FOOD SAFETY SYSTEMS, INC.
Food Safety & Quality Consultants
PACIFIC FOOD SAFETY SYSTEMS
Pacific Food Safety Systems (PFSS) provides a practical, science-based food safety and quality consulting service for food facilities registered with the U.S. Food and Drug Administration (FDA). We take a proactive approach to assist owners and operators better understand evolving food safety components in order to be in compliance with all federal food regulations including FDA’s Food Safety Modernization Act (FSMA). Our priority is your business success with the FDA. We are client-focused and support responsible and sustainable food systems based on a universal food safety culture.
Our Services
We are a Hawaii-based consulting firm that specializes in FDA HACCP and FSMA food Safety Plans
Research & Development
Achieve Your Goals
We are expert food safety and quality consultants who understand the regulatory approval processes required to bring commercially viable food products to market. We offer a full suite of services including label development, specialized processing methods with variance requirements, branding and marketing assistance, ingredient and raw material review, product testing, nutritional analysis, and relevant statistical methods aimed specifically at product research & development.
cGMP/HACCP
Comprehensive Audits and Inspections
Our qualified consultants help businesses prepare for FDA comprehensive cGMP/HACCP audits and inspections. We evaluate your firm’s level of food compliance with the Federal Food, Drug, and Cosmetics Act and other current laws and provide corrective guidance as needed. In addition we can assist with the readiness process for private third-party audits and other accredited certifications.
Sustainable Food Safety Systems
Expert Guidance
As a Hawaii-based consulting firm, we understand the diverse food cultures, businesses and commodities throughout the Pacific Region. We support the need for responsible sustainable food safety systems and recognize the complex regulatory environment that must be navigated to operate a successful business.
PFSS consultants are specialists who develop, design and implement food safety systems for facilities that grow, harvest, pack, manufacture, process, distribute, sell, warehouse, transport, or import any of the thousands of FDA-regulated products, or for those planning to do so! Specifically, we custom design and write food safety key requirement suppoprt documents, such as Hazard Analysis and Critical Control Point (HACCP) and Food Safety Modernization Act (FSMA) plans designed to assist the food industry achieve compliance with the FDA. We work with facility owners and operators to develop and maintain their food safety systems to assure compliance with all federal and state rules and regulations. We also work with Foreign Supplier Verification Program importers to verify that their imported food products meet U.S. safety standards. We are transparent with our consulting services and committed to helping businesses meet all FDA requirements.
We help foreign food businesses under FDA’s jurisdiction meet U.S. standards including new requirements mandated by FDA's FSMA.
PFSS offers similar services to foreign food and seafood facilities under FDA jurisdiction. These international services may also include the determination and evaluation of a facility’s compliance with FSMA and other applicable U.S. laws.
Our foreign food facility Inspections are to assist owners and operators identify potential food safety problems before products, including raw materials enter into the United States.
Our Priorities
We believe in strengthening your food safety systems with expert guidance. In doing so, we want you to be fully engaged and understand the FDA requirements of your food safety system.
Your Facility
Specifically, we inspect facilities for food safety hazards, unsanitary conditions (e.g., cross-contamination and cross contact events), storage, ingredient and raw material hazards, deficiencies in record keeping, supply chain verification, recalls, complaints, and general organizational or SOP practices. We design and implement product testing and environmental monitoring for certain facilities required to comply with FSMA. We can also provide technical assists with existing and new food processing, manufacturing, storage, and distribution facility designs to optimize your site-specific conditions.
FDA Compliance
We believe in strengthening your facility's food safety system and recognize that dealing with the FDA can be time-consuming and costly. Our consultants can assist you with remedial actions that may be needed to attain voluntary compliance with the FDA. These actions may include responding to general discussion items during a close-out meeting, Inspection Observations listed on an FDA Form 483, and Warning Letters. Our consultants are also available upon request to serve as food and seafood expert witnesses.
Food Safety Standards
We are passionate about food safety standards and dedicated to providing regulatory guidance to protect your food products by ensuring full FDA compliance as well as focus on innovative ways to bridge food safety and quality with sustainability to improve your business operations.
About Us
PFSS specializes in FDA food safety programs, cGMP/HACCP on-site audits and inspections, research and development initiatives, and promulgating sustainable food systems. Our FDA-experienced consultants assist small businesses as they establish and maintain strong, risk-based food safety standards. We support businesses by providing food safety guidance, consulting about product quality and improvement, and offer long-term guidance to strengthen entrepreneurship opportunities.
"the most sweeping reform of our food safety laws in almost 80 years"
We realize that small and start-up businesses are most likely to need our expert assistance to meet the new food safety requirements of the FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in almost 80 years. Our mission aligns with FSMA’s new safety rules by focusing on providing concise guidance to allow a proactive strategy that will prevent problems with the FDA rather than a reactive strategy of responding to FDA actions after problems have occurred. We want to build productive and successful relationships with our food and seafood industries, and we understand the challenges that small businesses will face with FSMA.
We recognize and appreciate the many unique food commodities in the Pacific region and specialize in simple, well-designed FSMA Food Safety Plans or HACCP plans for small businesses. We also continue to provide periodic consulting as needed to ensure implemented plans successfully pass biennial FDA audits or inspections. Additionally, we review and evaluate preexisting HACCP/FSMA food safety plans for efficiency and FDA compliance.
In the near future, the FDA will conduct on-site inspections for all registered food facilities in the United States. We want to strengthen food safety systems by conducting on-site cGMP or HACCP inspections while also helping owners or operators prepare in advance for routine FDA comprehensive surveillance inspections. This will help navigate and expedite the FDA inspection process and demonstrate good faith that businesses are committed to voluntary compliance. In doing so will reduce the firms’ overall time spent with FDA inspections. We can also help register food facilities or renew registrations with the FDA and other federal agencies.
Our Experts & Community
Donald Hawn, M.S. (President)
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Don has more than 25 years of experience working with FDA-regulated commodities and is a marine resource and seafood HACCP/FSMA Food Safety Systems specialist. Don’s prior federal work included serving as Consumer Safety Officers with both the U.S. FDA and NOAA Fisheries Service, Seafood Specialist with the Pacific Islands Regional Office, and a Research Fishery Biologist with the Pacific Islands Fisheries Science Center. Don has authored or co-authored over 25 science-related publications, and is a National scombrotoxin (histamine) formation subject-matter expert.
Don received an M.S. in Food Science from the University of Hawaii, a B.S. in Environmental Science from Western Washington University and an A.A.S. in Fisheries Science from Peninsula College.
Our Community
We believe in building meaningful and valued partnerships within the local community to help small food businesses comply with the FDA Food Safety Modernization Act. We understand that many markets are structured around food safety rules and our experienced consultants can help your business strategies meet the necessary regulatory requirements to succeed in this current economic environment. Whether you are a small or start-up firm that produces artisanal handcrafted specialty foods or a food wholesale distributor and Third-Party Logistics Provider for kindred products, your business is most likely to come in contact with the FDA. Our goal is to prepare and guide the nexus between you and the FDA by improving the efficiency of your food safety system.
Contact Us
For more information about FDA compliance or how a PFSS consultant may assist you, please contact us.
"We want to boost your company’s business and open market access with the development of a strong food safety program!"