With 30+ years’ experience, Ken Lehat Associates (KLA) helps importers follow FDA requirements. We can help your company prepare and comply with:
Start your FDA consultation with us today:
We have years of experience dealing with the Food and Drug Administration. Our fast, efficient, and professional FDA consulting services will help you and your shipments get through customs without hassle. We have a solid understanding of FDA Rules and regulations.
We always stay up to date with the FDA’s latest policies. This includes their latest Foreign Supplier Verification Programs (FSVP).
Our team can also help in removing your imported food products from automatic detention with the FDA.
When it comes to issues and assistance with the Food and Drug Administration, KLA’s FDA compliance consulting services have got all your needs covered.
We expertly guide you through the audit process. We ensure that the right documentation is provided, and the flow of goods is not interrupted by the FDA or the CBP.
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(Preventive Control for Human Food-PCHF)
At KLA, our PCQI trained and certified team guides your company through the newly implemented FSMA and FSVP regulations. Contact us to see how KLA can help your company comply with these food and beverage regulations.
KLA has provided well respected Dietary Supplements (DS) importers with FSMA guidance and support. We understand DS mandates and can help guide you through the complex maze of government regulations.
Modernization of Cosmetics Regulation Act (MoCRA) is now law. If you deal in cosmetics, you must be compliant with MoCRA. Look to KLA with confidence for expert guidance on becoming FDA compliant with MoCRA.
Look to KLA with confidence for expert guidance on becoming FDA compliant with MoCRA.
Remove all hassle and doubt when you deal with the Food and Drug Administration.
Food contact substances are items that come in contact with food. Whether it’s plastic packaging, colorants, or pots and pans, food contact substances must be approved in the same way that food products are. Look to KLA to comply with all aspects of these regulations.
The framework governing the regulation of medical devices is established in the Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FFD&C) Act. At KLA our expert consultants make sure that appropriate communication with the FDA takes place as we prepare your request for approval for new or modified devices. We can also handle a request for classification, device tracking, registration of foreign establishments associated with device production, and declaration of conformity.
The FDA has now put in place Sanitary Transportation Rules that will be implemented with shippers. Contact us to see how KLA can help guide you through these new regulations.
At KLA, we have experience working with animal food manufacturers helping them comply with PCAF (Preventative Control for Animal Food) regulations. Click learn more to see how we can help.
Navigating the complexities of FDA regulations can be overwhelming, but 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 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 and foreign supplier compliance, maintaining well-organized electronic records that can be readily provided to the FDA.
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