21 CFR part 111 Archives • dicentra

Supplier Qualification – Is your Supplier Qualified?

March 18, 2013 By dicentra

Supplier qualification is a requirement of the regulations, as set out by 21 CFR part 111.75. Setting up a proper supplier qualification program is an essential step in maintaining dietary […] Read More >>

FDA’s Increasing Enforcement Activities Highlight the Importance of Regulatory Compliance with respect to Dietary Supplement Liability Insurance

January 28, 2013 By dicentra

By: Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements Although many companies are aware of the need to have dietary supplement liability insurance, it is also important […] Read More >>

The Importance of an Effective, On-Going cGMP Training Program

August 13, 2012 By dicentra

On July 24, 2012 the FDA issued a Warning letter to United Nutrition Labs for continually failing to comply with current Good Manufacturing Practices (cGMPs) after a thorough on-site […] Read More >>

cGMP Enforcement Actions Escalating in the United States

July 30, 2012 By dicentra

By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements On July 16, 2012, the U.S. Food & Drug Administration (FDA) filed an injunction against a New York […] Read More >>

Complying with FDA 21 CFR Part 111 – Understanding the Process of FDA Inspections, FDA Form 483 & FDA Warning Letter Responses

July 11, 2012 By dicentra

What is FDA Form 483? The FDA has started conducting inspections of establishments that manufacture, process, pack, or hold dietary supplements without prior notice to determine the establishment’s compliance with […] Read More >>

Common Violations in cGMP Compliance Inspections for Dietary Supplements

May 14, 2012 By dicentra

Current Good Manufacturing Practices (cGMPs) for Dietary Supplements have been in effect since June 2010 and the FDA has been increasing inspections each year since. In 2011, 145 FDA inspections […] Read More >>

Supplier Qualification – Is your Supplier Qualified?

FDA’s Increasing Enforcement Activities Highlight the Importance of Regulatory Compliance with respect to Dietary Supplement Liability Insurance

The Importance of an Effective, On-Going cGMP Training Program

cGMP Enforcement Actions Escalating in the United States

Complying with FDA 21 CFR Part 111 – Understanding the Process of FDA Inspections, FDA Form 483 & FDA Warning Letter Responses

Common Violations in cGMP Compliance Inspections for Dietary Supplements

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Supplier Qualification – Is your Supplier Qualified?

FDA’s Increasing Enforcement Activities Highlight the Importance of Regulatory Compliance with respect to Dietary Supplement Liability Insurance

The Importance of an Effective, On-Going cGMP Training Program

cGMP Enforcement Actions Escalating in the United States

Complying with FDA 21 CFR Part 111 – Understanding the Process of FDA Inspections, FDA Form 483 & FDA Warning Letter Responses

Common Violations in cGMP Compliance Inspections for Dietary Supplements

SPEAK WITH OUR EXPERTS NOW

We will respond within one business day.

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