FDA Inspections

Overview of FDA Inspections

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.

FDA Crackdown on Compounding Violations

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 Restylane, Botox, intrauterine devices (IUDs), Juvederm and other variations of these drugs and devices. Such investigations have resulted in prosecutions for insurance fraud as well as Medicaid fraud and more.

DEFENSE TEAM SPOTLIGHT

Todd Spodek

Lead Attorney & Founder

Featured on Netflix's "Inventing Anna," Todd Spodek brings decades of high-stakes criminal defense experience. His aggressive approach has secured dismissals and acquittals in cases others deemed unwinnable.

NY Bar Admitted Multi-State Licensed Federal Courts

Meet the Full Team

Legal Scenario: What Would You Do?

Scenario

Federal agents execute a search warrant at your medical practice, seizing patient records and prescription logs.

Can they take patient records without patient consent?

Attorney's Answer

A valid federal search warrant overrides HIPAA privacy protections. However, the warrant must be properly scoped. An attorney can challenge overly broad warrants and move to suppress improperly seized evidence.

This is general information only. Contact us for advice specific to your situation.

Medical Device Regulation