Attorney at Law in NJ 1971 - 2006 / NJ Notary Public #2398815
The Vitamin Lawyer Third Party FDA cGMP Compliance Audit
FDA expects label-owners and manufacturers to have third-party compliance audits on a regular basis.
Starting in mid 2013 FDA began to more seriously implement its legal position that the Dietary Supplement Label-Owner is the legally responsible party (responsible for all Good Manufacturing Processes). It has done so by asking Label-Owners who are being inspected to show how they are auditing GMP compliance by the Label-Owner's Contract Manufacturer, Packager and Shipper.
Following a standard twenty page, 190+ item check list, we take a virtual tour of your contract facility (using Skype or similar) to provide my third-party FDA eGMP compliance audit.
The audit tour is recorded and the Audit Report includes extensive review of all GMP requirements together with still images from the tour, confirming compliance.
Contact me for pricing and reservation of time. The average audit takes 6 hours of my time; a couple hours of your time.
Direct Link to this web page:
Sample Report Cover Sheet
The Vitamin Lawyer Consultancy now offers, in addition to our SOP/GMP certification training programs, comprehensive Third-Party Audits of manufacturing, packaging and shipping facilities, to meet FDA requirements that Label-Owners are in a "state of control" over the production process. Using a standard check list, and recording the virtual or actual tour of the facility, we produce a 30+ page report covering all GMP requirements as set forth in the GMP Regulations.