Thursday, April 13, 2017

You Must Adhere to GMPs

It's been over two months since my last newsletter...
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FDA Injunction: You Must Adhere to GMPs

Doesn't matter who the president may be; the FDA continues on its bureaucratic way. As does Congress. 
Just last month we faced a failed health care reform that could have restricted dietary supplement access. See more here: .
While Congress flounders, see this about an FDA warning letter that led to a Court Order Permanent Injunction that the company immediately cease all operations:
“Companies that market their products with unproven health claims and also continue to violate manufacturing regulations put consumers’ health in jeopardy,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “The FDA will take the enforcement actions necessary to protect consumers from this undue risk.”
"The FDA inspected X’s businesses, which shared a location, four times since 2012. Despite assurances from X that the deficiencies noted during the inspections would be corrected, follow-up FDA inspections revealed that X repeatedly failed to make the necessary corrections."
"Because X’s businesses failed to follow cGMP regulations, their dietary supplements are adulterated under the Federal Food, Drug, and Cosmetic Act. Some of the supplements were also mis-branded because X’s businesses failed to properly list on the products’ label the number of servings per container and the correct serving size per container. Additionally, they failed to list each ingredient contained in the dietary supplements and identify the part of the plant each botanical dietary ingredient was derived from...."

Bottom line: companies that market their own products that they manufacture or label will be held to all manufacturing, holding and shipping GMPs. They will be expected to document compliance. Standard Operating Procedures are an essential element to remain in business.

I have continued to upgrade and update the SOP and training system from The Vitamin Consultancy. Here is how I can help your company:

1. Preparing SOPs that reflect your actual business practices and that conform to GMPs
2. Designing Control Systems that implement the SOPs
3. Training your staff in implementing the SOPs (FDA says it is not enough to have standard procedures, they must be written and your staff must be trained in using them).
4. Auditing your procedures and your contract manufacturer's GMP compliance.
July 2017 Update:OPS 4 SOPs

More here: 
GMP Audits here:

Contact me any time. I'm available to set your mind at ease.

Ralph Fucetola JD

A personal note, for those of you who don't know already. My friend and mentor, General Bert Stubblebine, died on 6 February 2017, his 87th birthday, after 158 days in hospital. We recount his and Dr. Laibow's struggle to save his life against the expectations of the medical system here:
Full FDA announcement here: