Newsletter - August 29, 2019
Just Because it is Sold on Amazon, Does not Mean it is Legal.
Online sale of illegal and/or low quality products, particularly those regulated by the FDA, is a major problem due to lax enforcement. But some websites are trusted more than others by consumers; Amazon is one of them. A product sold on Amazon is generally assumed by the consumers to be legally sold in the US, but it is far... Read More
FDA Explains the Expectations from cGMP Compliant Facilities
FDA expects all manufacturing facilities, big and small, new and old, to be equally compliant to its GMP requirements, but it is often hard for the new manufacturers to prioritize the various areas of compliance to be meet FDA’s expectations. In a recent conference presentation, FDA’s leaders from the Office of Pharmaceutical Quality... Read More
Just Because it is Sold on Amazon, Does not Mean it is Legal.
Online sale of illegal and/or low quality products, particularly those regulated by the FDA, is a major problem due to lax enforcement. But some websites are trusted more than others by consumers; Amazon is one of them. A product sold on Amazon is generally assumed by the consumers to be legally sold in the US, but it is far... Read More
FDA Explains the Expectations from cGMP Compliant Facilities
FDA expects all manufacturing facilities, big and small, new and old, to be equally compliant to its GMP requirements, but it is often hard for the new manufacturers to prioritize the various areas of compliance to be meet FDA’s expectations. In a recent conference presentation, FDA’s leaders from the Office of Pharmaceutical Quality... Read More
