US FDA Seeks More Power To Confront ‘Shadow’ Factory Challenges

 
• By Bowman Cox
  
Generate a summary of this article
Listen to this article
Beta

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find manufacturer of contaminated eye drops that disappeared.

Show and shadown factories
shining a light on show and shadow factories • Source: Shutterstock

In a series of recent actions, the US Food and Drug Administration has shown that there are still cases of hidden, substandard facilities manufacturing adulterated drug products for the US market and it will go to great lengths to prosecute such operations. It also is pressing Congress for new authorities that will give it a greater ability to identify such facilities and protect patients from them.

Historically, there have been issues in Asia with spotless “show” factories presented for inspection, with the actual manufacturing occurring in...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Distribution/Supply Chain

Akash test for clone

 
• By akash

Test article to check the clone issue

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

French Fine 11 Firms For Failure To Meet Stock Obligations

 
• By Ian Schofield

A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.

Responsible Antimicrobial Manufacturing A Must For UK’s Subscription Model Applicants

 
• By Eliza Slawther

The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.

More from Compliance

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By Vibha Sharma

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.