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Compliance Food and Drug Administration (FDA) Imports

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Arnall Golden Gregory LLP

Made in America? What Developers Need to Know About U.S. Supplement Facilities

Introduction - “Made in America” has strong consumer appeal, but in the dietary supplement industry, reality is far more complex. Roughly 75-80% of raw nutraceutical ingredients (like vitamin C, fish oils, amino acids, and...more

Gardner Law

What to Do When FDA Detains Your Shipment

Gardner Law on

When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more

Hogan Lovells

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Weintraub Tobin

New FDA Strategy Document for FSMA, Food Safety Modernization ACT

Weintraub Tobin on

The USDA has issued a new “strategy” document that outlines the agency’s direction with regard to implementing the Food Safety Modernization Act (“FSMA”). The document is intended to “to guide the next phase of FSMA...more

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