The Problem and Attorney General’s statement: It was found out that DNA barcoding tests commissioned by attorney general’s office on six popular herbal supplements found that of hundreds of bottles tested, 4 out of 5 contained none of the herbs listed on the labels. The supplements included ginseng, touted as an energy booster; Echinacea, marketed
Overseas Industry Links The list below is meant to be a comprehensive list of important overseas industry links that are helpful and useful for our clients. Click the title to go to the links. If you find a useful link that would be helpful to others, please email it to us (contact page), and we
Background: Parnell, former chief executive of the now-defunct company with plants in three states producing peanut butter and peanut paste used for its own products and as an ingredient in almost 4,000 others, was convicted by the 12-member jury for his role in a deadly Salmonella outbreak that began almost six years ago. The government
Clients are being notified of a recent development from the Notified Body BSI that it will be increasing the number of unannounced ISO audits for high-risk devices or for noncompliant manufacturers. The following Industry Update provides insight about their thinking on this new initiative. Background: After a trial period in March 2014 and a round
Background: Around 25% of the drugs being imported into the US are manufactured in India and in the past few years Indian drug makers were not being audit under tight compliance by the FDA. But due to some recent mishaps and bad experiences with some Indian companies like Ranbaxy and Wockhardt, the FDA has decided
Present Scenario: The US Food and Drug administration is appealing for feedback on its proposal to bring into line its medical device labeling requirements with those in the EU by permitting the use of standardized stand alone symbols on device labels providing these are clarified in a supplementary symbols glossary. Regulations in the US at
Background: The Department of Health and Human Services (HHS), of which the Food and Drug Administration (FDA) is a part, recently published “Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations.” Essentially, this Plan is the SOP for how HHS and FDA will operate under the current partial government shutdown. Under this
Physician Payment Sunshine Act Clients will be interested to know that American Medical Association (AMA) being the only governing body for physicians has come up with this new act called as Physician Payment Sunshine Act. This act demands the manufacturers of drugs, medical devices and biologics to record certain items and payments they have made
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
mdi Consultants