FDA Hammers Active Ingredient Maker Over 'Severe Hazard'

By Jeff Overley (February 12, 2014, 6:13 PM EST) -- A manufacturer of active pharmaceutical ingredients created a "severe hazard" by adopting substandard labeling and storage practices at plants in Arizona and Hong Kong, according to a U.S. Food and Drug Administration warning letter released Wednesday.

In one of the most notable findings, the FDA said that it encountered a container whose labels indicated the presence of an inactive ingredient, but that testing of the contents revealed a variety of different substances used to treat medical conditions.

"The unacceptable practices that resulted in this mislabeling incident can pose a severe hazard to consumers," the FDA wrote to CBSCHEM Ltd.

Separately, the...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Related Sections

Government Agencies

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!