Update eMemo – 9.05.2012
What Happens When The FDA Inspects: A Case Study
 A VITAMIN LAWYER CLIENT WAS JUST INSPECTED BY THE FDA
 Yes, You do Need Clinical Trials…
 Vitamin Lawyer Connections: All the Links You Need!
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.
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.
 Yes, you do need clinical trials! Further Services You Need!
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!
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…"
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