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FDA compliance should have an impact on every area of the pharmaceutical manufacturing industry. This is because the FDA regulates particularly strictly on the drug, medical devices and dietary supplements industries. The agency not only regulates every stage of the development of prescription drugs, including testing, manufacture, labelling, marketing, advertising, efficacy and safety, but it also has legislative power. FDA regulations are enforced in rigorous inspections of manufacturing premises and warehouses.

For manufacturers, passing an FDA compliance inspection is absolutely vital to their business, since penalties for failing to do so can be particularly heavy. Fines and prosecution can result from failed inspections, as can product recalls or bans, which can be damaging to brand reputation. In extreme circumstances the FDA can order the complete shutdown of a facility. Generally though, the FDA compliance inspection results in suggestions for improvements to manufacturing practices.

The FDA must give notice to a manufacturer before they can carry out an FDA compliance inspection. This allows manufacturers to prepare themselves and their facility. Keeping FDA compliance at the heart of daily operations is obviously the best way to avoid any problems on the day of the inspection. This means that employers should keep personnel up to date with the most recent regulatory developments in regular training sessions. Carrying out routine internal FDA compliance inspections should also be considered. This means that any weak points are identified and fixed early on.

Providing operating manuals detailing the appropriate way to carry out daily operations compliantly is a must. Furthermore, employers should also encourage employee vigilance concerning FDA compliance. Spotting and reporting anything that might present issues in an FDA compliance inspection could prevent serious problems later.

Regulations change constantly and new rules are introduced frequently. FDA auditing and training companies can help with FDA compliance.