FDA compliance impacts every aspect of the pharmaceutical manufacturing industry, or at least it should. This is because the FDA regulates particularly strictly on the drug, medical devices and dietary supplements industries. The agency has legislative power and regulates the testing, manufacture, labelling, advertising, marketing, efficacy and safety of the prescription drug industry. The FDA regulations are enforced in thorough inspections of warehouses and manufacturing plants.

For manufacturers, passing an FDA compliance inspection is absolutely vital to their business, since penalties for failing to do so can be particularly heavy. Failed inspections can lead to product recalls or bans, with the associated loss of public confidence, as well as fines and prosecutions. In serious cases of breach of regulations, the FDA can order a facility to be shutdown entirely. More often than not though the standard result of an FDA compliance investigation will be suggestions for improvements which should be made.

Before an FDA compliance inspection, the agency must give notice that they plan to carry out an inspection. This allows manufacturers to prepare themselves and their facility. Of course, keeping FDA compliance at the forefront of operations is the best way to avoid any nasty surprises on inspection day. Manufacturers should therefore provide regular training sessions in which personnel are kept up to date on regulatory compliance issues. It is also a good idea to carry out regular FDA compliance checks internally. This means that any weak points are identified and fixed early on.

Manufacturers should provide employees with access to operating manuals which give all the necessary information to operate in a compliant way. Furthermore, employers should also encourage employee vigilance concerning FDA compliance. Spotting problems now could prevent FDA compliance inspection failure in the future.

Regulations are altered and amended often and new rules are frequently introduced. Companies which are having difficulty ensuring FDA compliance have the option of getting professional training and auditing from FDA consulting companies.