Tuesday, August 20, 2013

FDA Seeks Reinspection Fees from Vitamin Companies; Are YOUR Papers in Order?


Sher Komisar, Compliance Coordinator
urges you to read Counsel Ralph’s
important message below -
then call her at: 914-966-8053
Read Counsel Ralph's new blog entry:
FDA Illegally Claims Reinspection Fees from Companies Like Yours!

"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

I am Ralph Fucetola JD and I have been called the Vitamin Lawyer because of my 40+ years of experience in the dietary supplement industry and in all of my 40+ years I have never seen the FDA more determined to pursue companies for being even slightly out of compliance.

Given the FDA has just hired 7,000 more Agentsthe chance that the FDA could be knocking on your door tomorrow morning is greater than ever.

This regulatory challenge has become more serious recently and the future appears increasingly dangerous for not just start-up and established vitamin companies, but for every physician, chiropractor or other health care practitioner who owns his or her own "private label" products.The Natural Products Association (NPA) warned us in an email June 2013:

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 warning. Do you also know how to prevent minor non-compliance from turning into a warning letter, or worse, a consent decree?”

I train your staff to bring your company into full regulatory compliance through my fairly simple four step process

1) Customization -- Working with your CEO I will customize my Standard Operation Procedures and Good Manufacturing/Marketing Procedures to you company's needs.

2) Set-Up  --  I work with your company for proper and precise implementation of the SOPs, including production logs, Product Claim Language control, definition & substantiation, and also 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'

4) Certification -- This is the final goal of the Compliance Program, receiving your Certification. Your whole team needs to be certified in the SOP procedures which I will customize for your company.

I’ve asked long-time natural products marketer and nutritional consultant Sher Komisar to coordinate the Program since my time will be needed for personal interaction with participating companies.   rf

But nothing will happen unless you pick up your phone now!
You Should Call Sher Komisar at 914-966-8053 
Thank you for reading Counsel Ralph’s message. I look forward to working with you, to prepare you for your FDA inspection.