Thursday, May 3, 2018

May 2018 eNewsletter: What We Can Learn from FDA Court Order


What Companies Can Learn From the Riddhi Vitamins' Cease and Desist Order*

Riddhi USA is a wholesale dietary supplement manufacturing company.  It manufactures products for label-owning marketing companies, like many of the Companies that receive the Vitamin Consultancy Newsletter.

After an inspection the violations were considered so egregious that a Federal Judge was asked to order Riddhi to stop all activities until it could meet GMP requirements.  Needless to say, all of its customers, Companies like yours, are scrambling to find new manufacturers.

What are the lessons we need to take from this regulatory action?

Let's start by listing what FDA thought were the most serious violations:
"-[1] failing to establish product specifications
    -- for the identity, purity, strength and composition of the finished dietary supplements

-[2] inadequate master manufacturing and batch production records

-[3] lack of quality control procedures

-[4] lack of procedures to investigate product complaints

-[5] products’ labeling failed to declare dietary ingredients, allergens and place of business."
These are nearly all Standard Operating Procedures violations. 

Either Riddhi did not have the written procedures or failed to implement them.  That also means the customers of Riddhi failed to "be in a state of control" -- the requirement that applies to all label-owners.

Specifications. Records. Procedures...

You need to have them. You need to implement them.  FDA publicized the Riddhi case as a warning to all companies that the agency can shut you down if you fail to adopt SOPs, train employees in their use, and actually implement them.

The Vitamin Consultancy provides up-to-day procedures and the OPS 4 SOPs system that enables you to implement the specifications, records and procedures required.

It is up to the Company's senior management to take the lead in careful implementation.

The SOP introduction indicates:

"The following Positions in the Company are listed in these SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager. The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO..."

That is:
Customer Service Manager
Warehouse Manager
The Vitamin Consultancy offers "refresher" training sessions where staff members assigned to the different positions mentioned in the SOPs can recommit to following the SOP procedures.

More information here:

Practice Note: Reading the FDA Regulation changing the way conventional food labels are configured.  The new Regulation is being delayed until 2020 (good news!).

     Yes, I was reading down the hundreds of Comments in the Regulation, and FDA's Responses. This one, #431, got a raised eyebrow, since it is contrary to what FDA has said elsewhere: "
We agree there is a difference in biological activity between synthetic and naturally derived β-carotene. "

     In the past FDA would object if any vitamin company said "natural" was better than "synthetic." Does that irrational rule still hold? If your naturally derived nutrient ingredient has been shown to be better than synthetic versions, it seems the old rule may no longer hold.


Proposition 65 Coming at YOU!

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