Reliable FDA Consulting
With 40+ years experience, Ken Lehat & Associates (KLA) provides FDA consulting services helping companies with:
Start your FDA consultation with us today.
We stay up to date with all FDA’s policies, including the latest Foreign Supplier Verification Program (FSVP).
We have 40+ years 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.
By constantly staying up to date with the FDA’s latest policies, we help our clients to have smoother interactions with this Agency, including the latest Foreign Supplier Verification Program (FSVP).
Our team is expert at 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.
Reliable FDA Consulting Services
Our knowledgeable staff is trained specifically in FDA rules and regulations, enabling us to offer a full service experience to domestic importers and foreign suppliers.
KLA prides itself on getting your FDA controlled goods into the United States. We specialize in dealing with complex shipments, even with previous problems like detentions.
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. We assure that appropriate records are on file as required by the FSMA/FSVP rules.
Food & Beverage Regulations
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. However, it becomes manageable if the proper documentation has been gathered ahead of time and records have been organized and maintained.
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.
PREVENTIVE CONTROL FOR ANIMAL FOOD
Imported food for animals and pets are under the same law as domestically produced animal and pet food. One needs to assure that importers and foreign suppliers are compliant and keep relevant records that can be provided to the FDA within 24 hours of their request.
The PCAF regulations are actually more complex than the PCHF regulations. The consequences for non-compliance can quickly cause death to animals and can be passed down to human food in certain cases.
As we have done for several animal food manufacturers, we will guide your company, anticipating the issues that could arise with animal and pet food.
This is a daunting task if you face regulations on your own, but it becomes manageable if the proper food safety has been anticipated and implemented and records have been organized and kept.
Remove all hassle and doubt when you deal with the Food and Drug Administration.
Dietary Supplement Regulations
The FDA has authority over Food Safety Compliance for Dietary Supplements (DS). They regulate 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.
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.
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 implemented with shippers.
“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. “