516.532.7259 | ken@kenlehat.com
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Expert FDA Consulting

With 30+ years’ customs experience, Ken Lehat & Associates (KLA) has helped hundreds of importers comply with FDA & FSVP requirement. We can help your company comply with:

  • FSVP Regulations
  • FDA Audits
  • Cosmetic Regulations/MOCRA
  • Dietary Supplements GGMP Regulations
  • Food Contact Substances
  • FDA Detention

We have helped hundreds of importers comply with FDA rules, helping shipments get through without hassle.

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Navigating FDA Rules & Regulation Compliance

Navigating the complexities of FDA regulations can be overwhelming.  With Ken Lehat & Associates (KLA), you gain a partner with unparalleled expertise. Our seasoned team is well-versed in all aspects of FDA compliance, offering comprehensive support to ensure your products and operations adhere to the strict standards imposed by US federal regulation.

Companies must adhere to the same laws for imported and domestically produced food and beverages. KLA’s PCQI-certified team specializes in helping your company navigate the Preventive Control for Human Food (PCHF) requirements. We ensure importer compliance with FSVP, MOCRA, Food Contact Substances, and FDA Detention rules to maximize shipment efficiency.

We have extensive knowledge and experience dealing with the FDA (30+ years).  We always stay updated with the latest regulations and trends.

For all your FDA compliance needs, visit our contact page to get in touch with us today.

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FREQUENTLY ASKED QUESTIONS

All of our agents have taken the neccesary FDA courwork and have years experience working with the FDA

The FDA needs all records related to food safety compliance for your facility(s) and your product(s). This includes records such as a hazard analysis, process flow charts, and a recall plan. We will help you organize these documents. We will help guide you through each regulatory step to ensure compliance.

The FDA regularly audits importers and their shipments. We will prepare you for the audit.

Prior to entry, you can designate us as your FSVP agent.  We can handle the entire audit on your behalf. 

When serving as your FSVP agent, we will implement all the steps required to comply with FSVP regulations.

Yes, all suppliers are required to have a food safety plan. As your FSVP agent, we will monitor current and new suppliers to ensure compliance.

Foreign importers must have a US based FSVP agent. We can serve as your FSVP agent and provide you with our UFI/DUNS code number.

MoCRA requires that your facility and products be registered with the FDA. Your company must designate a responsible person who substantiates the safety of the cosmetics and maintains adequate records. When importing, a US agent must be listed as the point of contact with the FDA.

Submissions for products are required and must include listing of the ingredients to assure they are not banned and allergens are accounted for.

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