Tuesday, December 10, 2013

Third Party FDA cGMP Compliance Audits


Memorandum from Ralph Fucetola JD
December 10, 2013
To: Vitamin Lawyer Contact List

FDA expects label-owners and manufacturers to have third-party compliance audits on a regular basis.

Following a standard twenty page, 190+ item check list, we take a virtual tour of your contract manufacturer 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; about an hour of your time. Reserve your Virtual Audit now; you should contact my Certification Program Coordinator, Sher Komisr here: 

#914.966.8053 - SOPclienthelp@gmail.com

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