FDA ASSISTANCE

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.

FDA Audit

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.

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 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.

Drug 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 409(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.

Dietary Supplement 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.

Cosmetics Regulations

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

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.

ANIMAL FOOD

(Preventive Control for Animal Food-PCAF)

FSMA and FSVP apply to Animal Food as well as Human Food. It is important to recognize that the regulations for Animal Food are not identical to the regulations for Human Food; for example, specific to Animal Food are the requirements to control additional chemical hazards such as nutrient deficiencies or toxicities (copper). At KLA, our PCQI certified team will ensure that your animal food products are FSVP compliant to enter the US Market.