Friday, September 7, 2012

09.05.12 - What Happens When The FDA Inspects: A Case Study

… Vitamin Consultancy
Update eMemo – 9.05.2012

What Happens When The FDA Inspects: A Case Study
Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
[1] Vitamin Lawyer Update eMemo Archives Updated!
[3] Yes, You do Need Clinical Trials…
[4] Vitamin Lawyer Connections: All the Links You Need!
[1] Vitamin Lawyer Update eMemo Archive Updated!
            I confess I outsourced finally bringing the Vitamin Lawyer Update eMemo Archives up to date. Over the next couple weeks you will find more of the past memos posted as blogs at: . Bookmark this page! The entries will be indexed for ease of searching.

[2] What Happened Last Week when a VL Client was Inspected by the FDA

At first, the FDA agents announced the inspection would probably take six days… then the Vitamin Lawyer-drafted SOPs (Standard Operating Procedures) documentation was provided to the agents. Two days later (four days less than predicted) the agents left, more satisfied than not. Just 5 minor Observations were issued, requiring changes in the SOP. This client’s experience will benefit all, as I have now updated the SOPs to cover the observations and to make other changes that will strengthen the process when other Vitamin Lawyer clients are inspected; as all will be, more regularly than in the past.

Observation 1:  To have documented qualifications of contract manufacturers and to institute a process to receive documentation from the manufacturer that each lot is approved prior to release.
Observation 2:  Document a quality control person in charge and to have written procedures for quality control responsibilities.
Observation 3:  Document procedures for holding and distributing operations in the proper environment and organizational procedures to prevent error or contamination.
Observation 4:  Develop an employee training manual and document training of employees.
Observation 5:  Document established procedures and operations to conduct when a product is returned and keeping records of returned products.

These changes are documented in revisions to the Standard Operating Procedures (SOPs). A specific Contract Manufacturing Agreement has also been developed, meeting GMP requirements. Vitamin Lawyer monthly retainer clients will receive the updated SOPs. Any others who have not yet completed their SOPs are reminded that “having one’s papers in order” is more necessary now than ever before.

[3] Yes, you do need clinical trials! Further Services You Need!
Several clients are raising funds to invest in Clinical Trials or Clinical Studies; I was asked to prepare a “Comfort Letter” for the clients to use with their potential investors. If you would like a copy addressed to your Company, to raise the funds you need to invest to stay in the market, please email me!

The Red Letter warnings I sent you in pastt months from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors?  I told you the 4 essential steps you must take in the last issue of the VL Update. Here, I add estimates of what these essential steps will cost your company. You need to budget now and start to do what you can to be prepared. The FDA has already dramatically increased inspections, without those new bureaucrats!

[4] Vitamin Lawyer Connections
Archived Cautions for CAM Wellness Practices
"Do you have a CAM “Alternative” health practice? Do you provide nutrients, remedies or health related items to clients?

Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients?

Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices.

I am known as The Vitamin Lawyer, because much of my 36 year legal practice centered around helping people in CAM practices, nutrient purveyors and advanced healthcare teachers. Today I am a Trustee of Natural Solutions Foundation. I can keep you out of trouble and operating smoothly so you can fulfill your mission to help others…"
This $99 PEL Webinar runs about an hour through 32 slides. It includes an 18 page eBook of information and forms all of which would cost over $500 if one on one. This is a Natural Solutions Foundation Benefit Webinar."

Vitamin Lawyer Connections…
Do you Skype? If so, free is one of the easiest ways to contact me, no matter where I may be.
My Skype handle is: vitaminlawyer
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And good advice… for you.
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Ralph Fucetola JD
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