3rd-Party FDA GMP Audit
Starting in mid 2013 FDA began to more seriously implement its position that the Dietary Supplement Label-Owner is the 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.
FDA reminds vitamin purveyors that the FDA does not guarantee that manufacturers are abiding by the cGMP requirements. It is up to the Label-Owner to assure the FDA that the product is manufactured under GMP conditions.
The Vitamin 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 194 item 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.
Expect to invest several hours of management time and about six hours of our time to produce a professional GMP Audit Report. Audit conducted by Ralph Fucetola JD and such other professionals as may be needed. Contact us to discuss details.
Let us provide you with our Third-Party Audit of Contract Facilities.