Reliable FDA Consulting Services
With years of experience, Ken Lehat & Associates (KLA) handles fda consulting services requirements in the following areas:
- NFDA Audit
- NFood & Beverage FSMA Regulations
- NAnimal Food FSMA Regulations
- NDietary Supplements CGMP Regulations
- NFDA Detention
- NCosmetic Regulations
- NFood Contact Substances
- NMedical Devices
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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 also always stay up to date with the FDA’s latest policies to better help our clients have smoother interactions with them. 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.
The FDA schedules a visit to your facility with Form 482 (Notice of Inspection) and is about to audit your imported products and requests your documents, make sure you speak with us first. We are experts at guiding you through the audit process to ensure that you provide the right documentation and that the flow of your goods is not interrupted by CBP and/or FDA.
When you are a KLA client, we prepare you well in advance of the audit by gathering documents and thus assuring that appropriate records are on file as required by the FSMA/FSVP rules.
Food & Beverage Regulations
(Preventive Control for Human Food-PCHF)
Imported Food & Beverage are under the same law as domestically produced food and beverage. One needs to assure that importers and foreign suppliers are compliant, keep relevant records and provide them to the FDA within 24 hours of their request. This is a daunting task if you face the FDA on your own, but it becomes manageable if the proper documentation has been gathered ahead of time and records have been organized and kept.
At KLA, our PCQI experts gather, analyze and keep the records in an FDA ready electronic file. Specifically our PCQI trained and certified team is here to guide your company through the newly implemented FSMA and FSVP regulations.
Dietary Supplement Regulations
FDA has authority over Food Safety Compliance for Dietary Supplements (DS): it regulates domestic as well as imported DS. Though most aspects of DS regulations are covered under CGMP rules, there are additional requirements specific to FSMA that must be adhered to. At KLA we have provided well respected DS importers with specific FSMA guidance and support.
Cosmetics Regulations & MoCRA
Modernization of Cosmetics Regulation Act (MoCRA) is now law and if you deal in cosmetics, compliance with MoCRA matters to your company. 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, and that there be a designated responsible person in your organization 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 qualify as food (section 201(f) of the FD&C Act.) and therefore are Subject to FDA’s FSVP Rules. Alternatively, Food Contact Substances as defined in section 209(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)) are “food” for the purposes of FSVP. Furthermore, food contact substances must be approved in the same way that food products are. KLA will guide you in all compliance aspects of the 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 interaction and communication with the FDA takes place as we prepare your request for new or modified devices for approval by the FDA. We can also handle a request for classification, device tracking, registration of foreign establishments associated with devices production, declaration of conformity
Logistics and Transportation
Transportation is an industry sector that was not previously regulated by the FDA. FDA has now put in place Sanitary Transportation Rules that will be slowly but surely implemented with shippers.
The PCAF regulations are actually more complex than the PCHF regulations. The consequences for non-compliance can quickly cause death to animals, can be passed down to human food in case of cattle animals and such animals destined to human consumption. As a result, your business can suffer tremendously.