Counsel Ralph teaching the SOP/GMP Certification Training for Global Healing Center, Houston, Texas.

FDA & FTC Are NOW Dramatically Increasing the Pressure!
All Dietary Supplement "Private Label" Owners
To be in Compliance with All Applicable Regulations.
FDA IMPOSES NEW CONTROL SYSTEM
HIRED 7,000 NEW AGENTS
"The FDA showed up unannounced. Said they’d be here for at least six days.  We showed them the SOPs Counsel Ralph prepared for us. They left after two days.
It was comforting to know we could call Ralph any time during this, and he was there for us."
A. C. Company CEO

WHO NEEDS THIS PROGRAM?
Anyone who owns their own
Dietary Supplement Labels. 
Meet FDA Requirements: Get Certified TODAY!
FDA Warning, May 2013: Private Label Distributors must: "...ensure that all phases of the production of [a] product are in compliance .."

ANNOUNCING
THE VITAMIN LAWYER REGULATORY COMPLIANCE
CERTIFICATION PROGRAM!
Online System With Quick Access!

PLEASE CONTACT MY PROGRAM COORDINATOR TODAY!
Sher Komisar: 914-966-8053
SOPclienthelp@gmail.com
Program Investment Value: Click Here
I am Ralph Fucetola JD and I have been called the Vitamin Lawyer because of my 40+ years experience in the dietary supplement industry.  I am ready to support your company's compliance with current lawful regulation.

This web site explains my Standard Operating Procedures Certification Program. It is  specially designed for the industry, including start-ups, but any company or practitioner that owns its own labels needs this program! Contract Manufacturers also need to know about this Compliance Program for their customers.

This Certification Program can save your company hundreds of thousands of dollars in regulatory costs!

Just embrace my four crucial steps to regulatory compliance. Choose the right program for your company. For the full Certification Program I provide:

[1] CUSTOMIZE – I can work with your CEO to to customize my Standard Operating Procedures and Good Manufacturing/Marketing Practices for your company

[2] SET-UP – I can work with your company for proper and precise implementation of the SOPs, including production logs, Product Claim Language control, definition & substantiation, and help you prepare the FDA required S&F Claims Notice.

[3] TRAINING - It's not enough to have procedures. The FDA says: train your team and prove they are qualified.

Your whole team needs to be certified in the SOP procedures I craft with you. I then train your team and provide the FDA acceptable Certification.

[4] The final goal of the Compliance Program -- meeting FDA training requirements and receiving your Certification.

I have several program choices designed for different classes clients. Please CLICK HERE to learn more about the different programs for your business needs.

The Gold Standard -
Vitamin Consultancy
Certification Program!

For More Information
And Video introduction,
CLICK HERE!
 
© 2012 / 2013
The Vitamin Consultancy Facebook Page: https://www.facebook.com/VitaminConsultancy
CERTIFICATION PROGRAM
ORDER HERE
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Private Member Entry 
Click Here
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REGULATORY COMPLIANCE NEWS

From Natural Products Association -
6.13.13 - "“FDA inspections involve a comprehensive look at your standard operating procedures (SOPs), equipment, laboratory controls, records, operating conditions, and more.  If areas of non-compliance are discovered, FDA could use any of these as evidence to issue a Form 483. ... [Learn] how to prevent minor non-compliance from turning into a warning letter, or worse, a consent decree?”
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Counsel Ralph Describes Why Your Company Must Focus on "Getting Your Papers in Order."
5.10.13 -- NEW FDA warning letter:
Obligations of private label distributors
  
"A new FDA warning letter outlines the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’."

http://www.nutraingredients-usa.com/Regulation/FDA-warning-letter-highlights-obligations-of-private-label-distributors

FDA News.com 3.27.13: 
"FDA on the hunt..."

"Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus..." 
Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec.  111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained."

Federal Register, page 34811
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Standard Operating Procedures
Dietary Supplement and
Natural Products
Development, Training & Deployment
A Regulatory Compliance Network™ Program
A Continuing Educational, Expressive Association Project of LifeSpirit Collaborative Congregations
A PEL Webinar Program