At FDA Compliance Simplified we enjoy working with companies of all sizes. Some of our clients are brand owners but not manufacturers. They team with contract manufacturers to produce shelf-ready products. This can sometimes make it hard to get the information we need to ensure [...]
Update February 17, 2022: Please use this link to view the UNPA webinar "In the BEginning"... Dietary Supplements Supply Chain Starts with Ag mentioned in the original post. The webinar opens with a general introduction and the presentations begin as indicated below. Good Agricultural and [...]
FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.
Successful launch of a product requires more than a good marketing plan. It is also important to know whether your product is subject to special regulations from various government agencies. While the Federal Trade Commission, Consumer Product Safety Commission and even the Environmental Protection Agency [...]
I hope that your business is doing well enough to allow you to relax a bit as summer starts. Knowing that your contract manufacturer complies with FDA’s current Good Manufacturing Practices (cGMPs) can reduce stress a bit. But how do you know that their cGMPs [...]
The folks at Pharmalot have written an article about the Johnson & Johnson consent decree. The article includes a link to the consent itself, which details the cGMP requirements FDA expects to see at the drug manufacturer's facility. The consent decree details the systems that need [...]