SupplySide West podcast: Are you ready for a FSMA audit?
August 15, 2018
In this SupplySide West edition of the Healthy INSIDER Podcast, Judie Bizzozero, editor, and Marian Boardley, principal at Marian Boardley Consulting LLC discuss Food Safety Modernization Act (FSMA) timelines and rules along with current data on FDA inspections.
Reporting and Analyzing Serious Adverse Events
Natural Products INSIDER July 13, 2018
Any manufacturer, packer or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit any serious adverse event reports (SAERs) they may receive.
Establishing a Good Raw Material Qualification Program…Natural Products INSIDER–Mar 17, 2016. Throughout 2015, the reliability of the dietary supplement raw material supply chain was called into question, notably by ..
by Marian Boardley – August 21, 2015. In hundreds of inspections carried out by FDA since 2009—based on inspection observations released by FDA, many …
Failing to Establish Specs is Most Common GMP Citation in …Natural Products INSIDER (blog)-Oct 1, 2015 Commenting last year on FY14 data that showed similar problem areas, independent consultant Marian Boardley wondered how firms could …
More Supplement Manufacturers Complying with FDA GMP Regulations, But Room for Improvement For the second year in a row, a greater percentage of dietary supplement firms that were inspected by FDA were found to be in compliance with manufacturing regulations, and of those businesses that received citations for noncompliance, FDA on average found fewer problems than in the previous year, according to public data.
FDA GMP Inspectors Cite 70% of Dietary Supplement Firms Natural Products INSIDER-May 20, 2013
In a previous analysis of publicly available FDA data, independent consultant Marian Boardley Consulting found the most common cGMP …
Quality Focus: GMP = Great Mountains of Paperwork …
www.nutraceuticalsworld.com/…/quality-focus-gmp-great-mountains-of-…
Nov 1, 2011 – Marian Boardley of the FDA Compliance Group LLC has put together useful summaries of FDA GMP inspection activities over the past couple …