by Brent Carter | Nov 2, 2022 | Blog
You have a cGMP program in place and are confident you are in compliance. Why does it matter if you include a 3rd party auditor like Carter Regulatory Group (CRG) to conduct audits of your systems and facility? Compliance is kind of like a stinky car – you get...
by Cory Carter | Aug 15, 2019 | Blog
Posted 25 July 2018 | By Cory Carter This article discusses current Good Manufacturing Practice (CGMP) requirements for companies making dietary supplements and who use contract manufacturers. The author highlights FDA comments on this issue, presents...
by Caden Carter | Mar 29, 2018 | Blog, fda-otc-drugs
Cosmetic companies often find they are making drug claims on their product mainly due to two parts of the definition of a drug. First, a drug claim is any claim that the product has an intended use in the “diagnosis, cure, mitigation, treatment, or prevention of...
by Cory Carter | Mar 27, 2018 | Blog, FDA Audits
Over the last 50 years, companies have relied heavily on lawyers from big firms to review labels, advise on advertising compliance, interface with the FDA on their behalf, etc. Today, there are FDA regulatory consulting firms, like our firm, who market services that...
by Cory Carter | Mar 14, 2018 | Blog
We meet dietary supplement companies regularly who are shocked when the FDA shows up to inspect their company for cGMP compliance when the company doesn’t produce any product. Is the FDA off their rocker? In short – no. All companies who market dietary...
by Brent Carter | Oct 17, 2017 | Blog, FDA Audits
One of the challenges of running a business with products produced for international markets is assuring your products will make it to their destination for distribution. Hours of planning, scheduling, paperwork, finding importers, shipping, and regulations….it...
