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FDA compliance forms an integral part of the working practices used by the companies which develop and manufacture medical devices and drugs. Ensuring compliance protects the public from risk when consuming certain new or existing products. The term FDA compliance is multi-faceted and incorporates regulations on several aspects of the industry including Good Manufacturing Practice, the packaging and labelling of products and marketing.

Because the FDA is an agency of the United States Federal Government it has the power to legislate and to enforce that legislation. Therefore, it can and does inspect companies under its regulation for compliance. In the food, drug, medical device and cosmetic industries, amongst others. FDA compliance plays an important role. The sole aim of enforcing FDA compliance is to safeguard the health of consumers by ensuring that products are consistently high quality.

FDA compliance should always be central to the daily workings of any businesses which are regulated by the FDA. Companies face grave consequences should they fail in their obligation to respect FDA regulations. Public injury and even death are both possibilities. This is especially true in the medicinal industry. The FDA prosecutes companies which do not follow regulations and fines and individual prosecutions are possible in serious cases. Also, the FDA does publish a list of those companies which have failed to comply.

Product recalls and seizures can be brought about by the FDA as well, which would be damaging to any company’s reputation, underlining the importance of FDA compliance. Some companies believe regulation is a hindrance and is too bureaucratic. Still, few would deny the importance of compliance for public health and safety. The FDA constantly works to try and make its regulations easier to follow, so as not to drain research resources. Several consultancy firms offer auditing services to help businesses ensure that FDA compliance does not become a problem.

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