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
An eye-opener on the FDA expectations for importers, distributors and private labelers of dietary supplements!!!
Our analysis of recent FDA warning letters issued to the dietary supplements industry signaled the FDA turned its GMP enforcement emphasis to the importers, distributors and private labelers of dietary supplements. However, time and time again, we see that many of our clients mistakenly believe that manufacturers or contract manufacturers of dietary supplements are the
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
In the future, you will be able to submit applications to Health Canada through the US Food and Drug Administration’s gateway. Health Canada is collaborating with its U.S. regulatory counterparts to reduce regulatory burden for health products, and to move closer to an automated environment for the exchange, review and management of information supporting the
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