USFDA ceases operations of drug and dietary supplement makers for violating cGMP and D & C Act.

USFDA ceases operations of drug and dietary supplement makers for violating cGMP and D & C Act.

USFDA ceases operations of drug and dietary supplement makers for violating cGMP and D & C Act.

March 14, 2017

On 14th March U. S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring Floren’s businesses to immediately cease operations.

This company has marketed its product on few websites. Marketing was also done in Colorado. This company has marketed their products without any proven health claims which continues to violate manufacturing regulations putting consumers health in jeopardy. USFDA has taken serious actions on the company.

USFDA inspected Michael’s business, and found out that company repeatedly failed to make the necessary corrections. USFDA has found that companies dietary supplement products were misbranded and they were using unapproved drugs. Some of the products of the company were marketed with treatment of high cholesterol, hypertension, diabetes, depression and muscle pain.

During scrutinisation of the company, USDA found that company was manufacturing product with high adulteration and were misbranding about the dietary supplements. USFDA has found that the company has violated current Good Manufacturing Practice (cGMP) regulations for dietary supplements which include failure to meet product specifications for identity, purity, strength or composition. Company failed to follow cGMP regulation and it has adulterated dietary supplement failing Federal food, D & C act.

Company failed to list the number of servings per container and serving size per container also they failed to list ingredients of the dietary supplement as well as the part of plant each botanical dietary ingredient

The consent decree prohibits company and its businesses from marketing misbranded or unapproved new drugs and adulterated or misbranded dietary supplements. Before company can resume operations, they must, among other things, recall their dietary supplements, hire labelling and good manufacturing practices experts and receive written permission from the FDA to resume operations.

Add Your Comment

Your email address will not be published. Required fields are marked *

The technical inputs, quality of work and translation output provided by M/s. InClinition, Dombivli, Mumbai, India were found satisfactory and meeting the latest standards. We recommend them for any kind of translation projects in future.

Dr. Ashish Mungantiwar
Dr. Ashish MungantiwarPresident-Medical Services, Mcleods Pharmaceuticals Ltd.

We found their suggestions and guidelines appropriate to our formulation range. InClinition Team has expert domain knowledge. They involved all our staff during conduction of audit and created positive approach towards audit. We strongly recommend their services and wish a continued support from them.

Mr. Nandkishor Deshpande
Mr. Nandkishor DeshpandeDirector, Debco Homeopathic Pharmaceuticals

On occasion of InClinition's 1st International Scientific Conference, we wish a grand success to conference.

Mr. Pranab Mukherjee
Mr. Pranab MukherjeePresident, Republic of India
Phone: +919696097866 /+912512400397
S2 and 3, Shri Devdoot CHS, Near Bhoir Gymkhana,
Dombivli West-421202, Mumbai Area, India