FDA Consulting

Reliable FDA Consulting Services

With 40+ years experience, Ken Lehat Associates (KLA) handles FDA requirements in the following areas:

  • FDA Audit
  • Food & Beverage FSMA Regulations
  • Animal Food FSMA Regulations
  • Dietary Supplements CGMP Regulations
  • FDA Detention
  • Cosmetics Regulations & MoCRA
  • Food Contact Substances
  • Medical Devices

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fda consulting services

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 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) regulations.

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.

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FDA AUDIT

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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Food Safety

Food & Beverage Regulations

(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.  Click learn more to see how KLA can help your company comply with these food and beverage regulations.

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Dietary Supplement 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.

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Cosmetics Regulations & MoCRA

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.

  • 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.
  • Even Cosmetic Contract Manufacturers are required to register.
  • Submissions for products are required and must include listing of the ingredients to assure they are not banned and
    allergens are accounted for.
  • MoCRA requires changes to existing labeling requirements.

Look to KLA with confidence for expert guidance on becoming FDA compliant with MoCRA.

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Remove all hassle and doubt when you deal with the Food and Drug Administration.

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Food Contact Substances

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.

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Medical Device 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.

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Logistics and Transportation

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.

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Animal Food

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.

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Expert FDA Consulting Services

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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