FDA compliance has been much more difficult to deal with By Alan Schwartz What is going on with the FDA? Is the FDA on a war-path judging by the ever increasing number of facility inspections? Or is it like any bureaucracy, they have taken on too much work without clearly assessing the consequences for companies,
Recently, there was a warning letter issued to a company (dated Sept 11, 2012) that was registered as a “specification developer” with the FDA. The inspection of the company was conducted by the FDA on June 7, 2012. However, this article is not about the company and what they manufactured or what they distributed. This
Orally Disintegrating Strips as dietary supplements, an easier pathway adopted by many companies to enter US market
GFda Information Artical FDA Says A BIG NO. Find out WHY Background and some few Clarifications of some definitions by FDA: Dietary Supplement: A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet which includes: vitamins, minerals, herbs or other botanicals, amino acids, and substances such
On December 9, 2011, Alan Schwartz was an invited guess speaker to at a seminar for the Shandong, China, FDA delegation. The attendees at this seminar are on a fact finding visit to learn more about the US FDA and the US pharmaceutical and medical device industries. The attendees are all top offices of the
Published in GXP Lifeline
Two former Synthes Inc. executives were sentenced to nine months in prison and a third sentenced to five months in prison for their roles in the medical-device maker’s promotion of bone cement for unauthorized uses. U.S. District Court Judge Legrome Davis sentenced Michael D. Huggins, who was chief operating officer of Synthes, and Thomas B.
Letter to Foreign and Domestic Medical Device and Component Establishments That May Be Affected by the March 2011 Japan Earthquake and Tsunami
Japan is a critical participant in the global medical device market. on March 11, 2011, a massive earthquake and tsunami occurred near the northeastern coast of Japan, followed by various aftershocks, causing extensive damage to this region. The United States Food and Drug Administration (FDA) regrets any destruction or loss caused by this unforeseen disaster.
Rockland County Department of Health, Rockland, NY urges all residents not to use products known to contain lead The Rockland County Department of Health announces that there were two recent New York City adult lead poisoning cases that have been associated with the use of Ayurvedic medicines manufactured and purchased in India. The products used
Food recalls across the United States seemed to be everyday news last year. Eggs, beef, tuna and lettuce just to name a few-were all recalled at one time or another for a variety of reasons. Recent year, lawmakers hope new legislation will eventually make food recalls rare news events. President Obama signed the Food Safety
Food Services Update: September, 2010 Many food suppliers and/or manufactures are being brought into the 21 Century. For the past 30 years the pharmaceutical and medical device industries had to comply with a whole set of complex regulatory requirements both from the US FDA and/or foreign governments. There is the FDA cGMPs, FDA QSR/cGMP, ISO