FDA Consulting assistance with FDA Regulations, FDA Compliance and FDA Validation
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The U.S. customs and FDA work closely and recently while doing a spot examination of a mail shipment of foreign drugs, the US Customs revealed that such shipments usually contain counterfeit and unapproved drugs that create severe safety problems. This joint operation by customs and FDA was carried out to help customs and FDA stop counterfeit and potentially unsafe drugs from entering the United States. Ideally this is the task of compliance programs.
CFSAN and the effects FDA compliance failure
FDA compliance programs are documents created by agencies that guide Agency field offices for investigations, inspections, sample collections, sample analysis, and regulatory activities in defined program areas, such as domestic seafood and pesticides in domestic foods. FDA compliance is necessary for the businesses selling food, cosmetic and medical products in the US. FDA compliance standards issued by CFSAN are updated every 3 years but for some programs they are re-issued sooner due to changes in procedures, regulatory concerns, etc. One such standard for compliance is FDA's Quality Systems Regulation (QSR). Complaint handling and reporting requirements are an integral part of the FDA QSR.
For businesses dealing with food products, FDA anticipates that it, or a state agency acting on its behalf, will discover a domestic facility's failure to be registered during a routine food safety inspection. During the inspection the inspector will check for FDA validation with respect to the validity of the registration. If the facility is not registered, then that is brought to the notice District FDA Compliance Branch.
Regulatory action can take place in cases of continuing failure to register and in cases which may cause a threat to food supply, adverse health or death to people or animals. In addition, FDA may also consider the failure to register as an additional charge in a legal action on other statutory violations.
For foreign facilities, the FDA law generally enforced is based on the registration requirements in accordance with the policies set out in the "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002" (revised November, 2004)"
To avoid such experiences, FDA Registrar Corp helps companies comply with U.S. FDA standards and regulations such as:
* U.S. FDA Food Facility Registration * U.S. Customs and FDA Prior Notice (Forms to ship food and beverages to the USA) * U.S. Food Labeling Regulations * U.S. Food Canning Establishment Registration (FCE) and Process Filings (SID) * U.S. FDA Medical Device Establishment Registration * U.S. FDA Medical Device Listings * U.S. FDA Cosmetic Registration * U.S. FDA Cosmetic Formulation Filings, etc.
FDA compliance made quick and easy!
It is often difficult to comprehend FDA standards and regulations. So, FDA Registrar Corp makes it convenient for companies to overcome the hurdles of complex paperwork required by FDA law. This FDA consulting support is particularly helpful to non-U.S. companies that may need to overcome language barriers, time barriers and cultural barriers with regard to U.S. government paperwork and requirements.
At www.fdaregistrar.com you can receive information about FDA regulations as well as FDA validation requirements.
Russell K. Statman, Esq., is a founder and Executive Director of <a href="http://www.fdaregistrar.com">FDA Registrar Corp.</a>, a firm providing registration, compliance assistance and U.S. Agent Services for the food and beverage, cosmetics and medical device industries. Mr. Statman is an attorney-at-law representing firms in FDA-regulated industries for the past eighteen years. Contact the author at: statman@fdaregistrar.com
Disclaimer: The information presented and opinions expressed herein are those of the authors and do not necessarily represent the views of ArticlePros.com and/or its partners.
