Reliable FDA Consulting Services
With 40+ years experience, Ken Lehat & Associates (KLA) handles FDA requirements in the following areas:
- NFDA Audit
- NFood & Beverage FSMA Regulations
- NAnimal Food FSMA Regulations
- NDietary Supplements CGMP Regulations
- NFDA Detention
- NCosmetics Regulations & MoCRA
- NFood Contact Substances
- NMedical Devices
Start your FDA consultation with us today by:Clicking here
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.
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.
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.
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.
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.
- MoCRA authorizes the FDA to inspect facilities and their records to enforce mandatory recalls on products.
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
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.
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.
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.
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.
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.
Comprehensive FDA Audit Preparation and Support
The prospect of an FDA audit can be daunting. We bring years of experience to the table, guiding your business through audits with ease. Our preparatory work, thorough document collection, and adherence to FSMA/FSVP rules position you to provide the right documentation. This will help mitigate potential interruptions to your flow of goods by the CBP and/or the FDA.
The FDA’s Sanitary Transportation Rules present new challenges for shippers. KLA stays ahead of implementation to help transition your logistics and transportation sectors into full compliance.
Start your journey to hassle-free FDA compliance today. Keep up with the evolving landscape of FDA rules and ensure that your shipments move through without any delay.
Our dedication to staying abreast of the FDA’s latest policies, such as the Foreign Supplier Verification Programs, means we are well-positioned to support you in managing smoother interactions with the agency.
Contact us to navigate the intricacies of FDA compliance with confidence and professionalism.