FDA Defense Lawyers for Inspections, Investigations, and Cases in San Francisco
San Francisco address – by appointment only:
201 Spear Street Suite 1100
San Francisco, CA 94105
888-680-1745
As a critical entry point for products and materials imported from China and Canada, San Francisco is one of the epicenters of the U.S. Food and Drug Administration’s (FDA) law enforcement efforts. FDA agents routinely inspect shipments coming into (and going out of) the Port of San Francisco, and investigations targeting local businesses and individuals are common as well. If the FDA is targeting you or your business, you should speak with an FDA defense lawyer promptly.
At Oberheiden P.C., we defend businesses and individuals in all FDA-related matters. This includes inspections, investigations, administrative and civil enforcement proceedings, and criminal prosecutions involving the U.S. Department of Justice (DOJ). We provide FDA compliance representation as well—helping our clients avoid and remedy issues that have the potential to lead to unwanted scrutiny.
We Represent Importers, Exporters, Manufacturers, Distributors, Health Care Entities, and Other Clients Facing FDA Scrutiny in San Francisco
FDA inspections and investigations can lead to severe consequences. While the FDA has the authority to prevent the importing, exporting, and distribution of non-compliant products, it also has the authority to impose civil fines and other penalties. In addition, if an inspection or investigation uncovers evidence of criminal activity—such as intentionally importing misbranded goods or distributing materials used to manufacture controlled substances—the FDA’s inquiry can lead to federal criminal charges. As a result businesses and individuals facing inspections and investigations need to be extremely careful, and they need to make informed decisions based on the advice of experienced FDA defense counsel.
Our FDA defense lawyers represent clients in San Francisco that are facing scrutiny related to all commercial activities and products that fall within the FDA’s enforcement jurisdiction. This includes representing importers, exporters, manufacturers, distributors, health care entities, and other clients in matters involving medications, medical devices, foods, cosmetics, and other consumer products.
Dr. Nick Oberheiden
Founder
Attorney-at-Law
John W. Sellers
Former Senior Trial Attorney
U.S. Department of Justice
Local Counsel
Joanne Fine DeLena
Former Assistant U.S. Attorney
Local Counsel
Lynette S. Byrd
Former Assistant U.S. Attorney
Partner
Amanda Marshall
Former U.S. Attorney
Local Counsel
Aaron L. Wiley
Former Federal Prosecutor
Local Counsel
Roger Bach
Former Special Agent (OIG)
Gamal Abdel-Hafiz
Former Supervisory Special Agent (FBI)
Chris Quick
Former Special Agent (FBI & IRS-CI)
Kevin M. Sheridan
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Dennis A. Wichern
Former Special Agent-in-Charge (DEA)
FDA Matters We Handle in San Francisco
When facing an inspection or investigation, it is critical to ensure that you understand why the FDA is taking action. The FDA’s enforcement authority is broad, and its inspections and investigations can target a wide range of alleged statutory violations. Our lawyers represent clients in all FDA-related matters in San Francisco, including (but not limited to):
Import-Export Investigations
The FDA closely monitors import and export activities in San Francisco, specifically in relation to medications, medical devices, and other consumer products. As the FDA explains, all regulated products imported into the United States must meet the same standards as those manufactured domestically. To enforce this mandate, “products are subject to inspection when offered for import into the United States . . . and may be refused entry if they appear, from examination or otherwise, to violate FDA requirements.”
But, as noted above, refusal of entry is just one of several potential consequences of an FDA import inspection. Violations of the federal Food, Drug, and Cosmetic Act (FFDCA) and other federal laws can also lead to other penalties. Exporters can face FDA scrutiny as well, including those that deal in so-called “import for export” or “IFE” goods.
Misbranding
The FDA also prioritizes enforcement in the area of misbranding. Under Section 502 of the Food, Drug, and Cosmetic Act, a product can be considered “misbranded” under the following circumstances (among many others):
- “Its labeling is false or misleading in any particular;”
- “It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;”
- “Any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated;”
- “It is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling;” or,
- “The [manufacturer or seller] is not registered with FDA as required by Section 510 of the FFDCA and has not listed the device as required by Section 510(j) of the FFDCA or obtained applicable premarket notification clearance as required by Section 510(k) of the FFDCA.”
Importing, exporting, and distributing misbranded products that are subject to the FFDCA are violations that the FDA takes very seriously—especially when the products in question present a risk of harm. Companies in San Francisco that deal in third-party goods must address the FFDCA’s branding and labeling requirements proactively, as turning a blind eye to violations can lead to prosecution even if a company is not directly responsible for a product’s misbranding.
Counterfeiting
Misbranding and counterfeiting are related but distinct violations of the FFDCA (and potentially other federal laws). The FDA also aggressively targets counterfeiting operations—including operations involving the manufacture of counterfeit products domestically and abroad. Companies and individuals can face prosecution for importing, exporting, manufacturing, and distributing counterfeit products ranging from counterfeit drugs to counterfeit patented and trademarked consumer products.
In counterfeiting cases, the FDA often works closely with other federal agencies to execute large-scale takedowns. This includes the DOJ, U.S. Customs and Border Protection (CBP), Drug Enforcement Administration (DEA), and Federal Bureau of Investigation (FBI). When these other agencies are involved, it is not unusual for FDA inspections and investigations to lead to multiple charges for FFDCA violations, conspiracy, money laundering, wire fraud, and other crimes.
Distribution of Material Used to Manufacture Controlled Substances
One particular area of focus for the FDA in San Francisco has been cracking down on the importing and distribution of materials used to manufacture controlled substances. This is a specific criminal offense under 21 U.S.C. Section 843(a)(7). Individuals targeted by the FDA under Section 843(a)(7) can face statutory fines and up to four years of federal imprisonment (and more in some cases) if involved in efforts to:
“[D]istribute, export, or import any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to manufacture a controlled substance or listed chemical, knowing, intending, or having reasonable cause to believe, that it will be used to manufacture a controlled substance or listed chemical . . . .”
Similar to counterfeiting and other violations falling within the FDA’s enforcement jurisdiction, violations of Section 843(a)(7) will often lead to other charges as well. It is not unusual for individuals targeted for distributing materials used to manufacture controlled substances to face multiple charges carrying the potential for six or seven-figure fines and a decade or more in prison.
Health Fraud Scams
The FDA is also aggressively targeting entities and individuals in San Francisco suspected of having involvement in “health fraud scams.” This includes both: (i) importing, misbranding, counterfeiting, and distributing unapproved medications and medical devices; and, (ii) charging excessive prices for medications and medical devices to patients, insurance companies, and government payors. In addition to the FFDCA, health fraud scams implicate the False Claims Act, federal health care fraud statute, and various other federal laws as well; and, here too, individuals and entities targeted by the FDA can face substantial penalties in administrative, civil, and criminal enforcement proceedings.
FAQs: Avoiding Penalties in FDA Enforcement Cases in San Francisco
What Should Companies Do During FDA Inspections and Investigations?
If you or your company is facing an FDA inspection or investigation, your first step should be to engage experienced defense counsel. You will need to work with your defense counsel to assess your risk, and you will need to rely on your defense counsel to deal with the FDA on your behalf. While these inquiries can have significant consequences, it is possible to avoid these consequences in many cases—but doing so requires an intimate understanding of the substantive and procedural issues involved.
What Penalties Can the FDA Impose for Importing, Exporting, Distribution, and Other Violations?
The FDA can directly impose a variety of administrative and civil penalties for importing, exporting, distribution, and other violations. This includes refusing entry, denying or withdrawing approval, and assessing fines—among other sanctions. Crucially, if the FDA finds evidence of criminal misconduct during an inspection or investigation, this finding can also lead to criminal prosecution by the DOJ.
How Can Companies and Individuals Defend Against Alleged FFDCA Violations?
The FFDCA is a complex statute, and there are several ways to defend against alleged violations. With that said, determining what defenses you or your company can assert during an FDA enforcement proceeding requires an in-depth assessment of the specific facts and issues at hand.
What Should I Do if My Company in San Francisco has Violated the FFDCA?
If your company in San Francisco has violated the FFDCA, you will want to work with outside FDA counsel to remedy the issue as quickly as possible. Proactively remedying known violations can significantly reduce the enforcement risks involved, although companies must continue to be careful when dealing with the FDA directly.
Why Should I Choose Oberheiden P.C. for FDA Defense in San Francisco?
Our firm’s FDA defense lawyers are highly experienced on both sides of federal law enforcement matters. We have represented numerous clients in cases involving the FDA, and several of our attorneys previously prosecuted FDA fraud cases at the DOJ. We have succeeded in helping the vast majority of our clients avoid federal charges, but we also have a well-established track record of success at trial.
Schedule a Complimentary Consultation with a San Francisco FDA Defense Lawyer at Oberheiden P.C.
If you need an FDA defense lawyer in San Francisco, we encourage you to contact us promptly for more information. Please call 888-680-1745 or send us a message online to arrange a complimentary consultation.
