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Faced 5+ Years in Prison

People Vs Joseph Amico

Covered by NYDaily News. Las Vegas man accused of threatening a prominent attorney and making vile remarks.

Faced 10+ Years in Prison

People Vs. Anna Sorokin

Covered by New York Times, and other outlets. Fake heiress accused of conning the city’s wealthy, and has an HBO special being made about her.

Faced 3+ Years in Prison

People Vs. Genevieve Sabourin

Accused of stalking Alec Baldwin. The case garnered nationwide attention, with USAToday, NYPost, and other media outlets following it closely.

Faced Potential Charges

Ghislaine Maxwell Juror

Juror who prompted calls for new Ghislaine Maxwell trial turns to lawyer who defended Anna Sorokin.

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FDA Inspections Lawyers

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.

Crackdown
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.

FDA Investigations
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.

Deficiencies
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.

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I was searching for a law firm with some power to help me deal with a warrant in New York . After 6 days I decided to go with Spodek Law Group. It helped that This law firm is well respected by not only the top law firms in New York , but the DA , Judge as well. I...

~Fonder Brandon

5 Stars
It was my good fortune to retain Spodek Law Group for representation for my legal needs. From the beginning, communication was prompt and thorough. Todd, Kenneth and Alex were the first people I worked with and they all made me feel comfortable and confident that the team was going to work hard for me. Everything was explained and any concerns...

~A G

5 Stars
After meeting with several law firms, I chose the Spodek Law Group not only for their professionalism and experience, but for the personal attention given to me right from the initial consultation. It is important to recognize how crucial having the right legal team is when faced with potentially life altering events that impact families and the lives of loved...

~George Cherubini

Spodek Law Group

White Glove Service

We Provide Superior Service, Excellent Results, At A Level Superior To Other Criminal Defense Law Firms. Regardless Of Where Your Case Is, Nationwide, We Can Help You.
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