Ben Venue Signs FDA Consent Decree Over Drug Manufacturing Problems

• FDA cGMP QSR GMP Training - online training courses taught by SkillsPlus International Inc.

Updated October 19, 2020

The link in the original post broke.

You might also like:

Ben Venue Signs Consent Decree With FDA To Address Manufacturing Problems at Plant - Bloomberg Law

- - -  original post follows below  - - -

Ben Venue Signs Consent Decree with FDA Over Drug Manufacturing Problems | Fox Business:

"Ben Venue Laboratories, the contract drug manufacturer whose quality lapses caused a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil and recalls of numerous other drugs, reached an agreement with U.S. authorities governing the company's efforts to fix the problems.

Ben Venue, a Bedford, Ohio, division of Germany's Boehringer Ingelheim, signed a so-called "consent decree" with the Food and Drug Administration, according to a company statement and court documents filed by the Department of Justice in federal court in Ohio.

The consent decree bars Ben Venue from making and selling certain drugs until the company can demonstrate that it has taken certain steps to correct its manufacturing problems, among other requirements."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

------

• FDA cGMP QSR GMP Training - online training courses taught by SkillsPlus International Inc.

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Closes Down Another Dietary Supplement Company

Updated September 17, 2024

You might also be interested in:

Dietary Supplements - FDA

---  the original post follows below  ---

Another dietary supplement company, PUH, closed down by FDA:

"Pharmacist’s Ultimate Health of St. Paul, Minnesota agreed to a consent decree to cease their unlawful distribution of unapproved new drugs and adulterated dietary supplements. They have to stop distributing their products until all disease claims are removed from their websites and product labels and they comply with cGMP requirements for dietary supplements.

The company marketed products capsules, topical creams, and botanical extracts under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy. The product names include Allergy Relief Complex, Lycopene Standardized Extract, Co Q-10, Cold and Flu Defense, Cholesterol Homocysteine, Prostate Companion, Ginger Root Standardized Extract, and Progesterone Cream, among others."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store