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Inspections of regulated facilities by the Food and Drug Administration (FDA) are performed to determine their compliance with laws and regulations pertaining to their operation. The FDA will release a certain portion of the information obtained from these inspections to help the public develop an increased understanding of how it works to protect the public health. There are also portions of an inspection that will not be released until final enforcement action is completed.
Because of the violations taking place concerning sterile techniques involved in compounding, there has been a crackdown by the FDA on certain pharmacies. These violations involve a lack of quality control, foreign manufactured ingredients that lack pedigrees and more. Legislation and regulations have been put in place by state boards of pharmacy, the FDA, as well as state legislatures to make certain the compounding of medications is more closely monitored.
High Profile Investigations
There are many high-profile investigations being performed by the FDA. They involve drug manufacturers as well as physicians. The results of these investigations have caused drug manufacturers to be sanctioned for several millions of dollars. They were found guilty of not complying with proper manufacturing practices. FDA’s investigation of physicians has shown some of them obtained foreign-sourced Restyline, Botox, intrauterine devices (IUDs), Juviderm and other variations of these drugs and devices. Such investigations have resulted in prosecutions for insurance fraud as well as Medicaid fraud and more.
Medical Device Regulation
The Center for Device and Radiological Health (CDRH) is a part of the FDA and is responsible for regulating medical devices. This includes mammogram machines, x-ray machines and more. The FDA is responsible for making certain the facilities using this equipment are properly certified. Should a facility not obtain and maintain the proper certification, it can lose the right to provide services using these devices. It could also result in criminal, civil as well as administrative sanctions.
Applicable Rules And Laws
Healthcare providers, as well as exporters, manufacturers, importers, and distributors involved in the healthcare industry, must be aware of all the laws and rules that apply to them. It is also essential they know how to properly react when a breach occurs. The laws in place are designed to regulate the healthcare industry are complicated. Violations can cause a company to be made criminally liable for their action or inaction. They could also face disbarment, administrative penalties involving losing their profits, fines and more.
The FDA Office of Criminal Investigations (OCI) is also part of the FDA. It investigates any type of possible violation of the Food, Drug and Cosmetic Act (FDCA) as well as any applicable statutes. Regulatory inspections, as well as compliance audits are conducted by the FDA’s Office of Regulatory Affairs. The Department of Justice (DOJ), as well as the Health and Humans Services (HHS), also conduct investigations on behalf of the FDA. They focus on possible issues of harm involving patients.
When a person or organization associated with the healthcare industry is contacted by the OCI or the FDA Office of Regulatory Affairs with a notice of inspection deficiencies, it needs to be carefully reviewed. Legal experts will know what actions are necessary when responding to all deficiencies listed. An innocent mistake made when providing a response could cause serious future problems.
It is possible a company could be required to appear before a formal or informal administrative hearing. The nature of any possible enforcement will be determined by the type of violation. It could involve something as serious as criminal prosecution or simply a letter of notification requesting a correction. An experienced and knowledgeable attorney will know the best way to handle the FDA’s accusation of deficiencies. They can help in clearing noncompliance issues, defend against complaints trying to obtain civil monetary penalties, other forms of administrative hearings and more.