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 Administration’s 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 or 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.
Our knowledgeable staff are trained specifically in FDA rules and regulations, enabling us to offer a full service experience to domestic importers and to foreign suppliers. KLA Prides itself on getting your FDA controlled goods into the USA. We specialize in dealing with complex shipments, even with previous problems like detentions, to achieve smooth sailing.x
When 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.
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 and 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.
FDA has authority over 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.
FDA has authority over marketed Cosmetics under separate acts: per FDA “The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA)." One should be aware that Cosmetics are not FDA-Approved, but are FDA-Regulated. On a separate note, color additives used in manufacturing Cosmetics are regulated by the FDA regulations on food. KLA will guide you on becoming compliant for all parts of the regulations.
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.
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.
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.
When it comes to the Food and Drug Administration, it’s best to work with a customs broker that has enough knowledge and experience to get your shipments through efficiently and professionally. Trust our FDA regulatory consulting services to help you have smoother dealings with the Administration.
Secure your shipments and gain your peace of mind when you consult with our team today.