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

 
• By Bowman Cox

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...

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More from Distribution/Supply Chain

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

Oz: CMS Developing Plans To Incentivize Domestic Manufacturing

 
• By Sarah Karlin-Smith

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.

New US FDA Program Encouraging Domestic Manufacturing May Be ‘Very Selective’

 
• By Sarah Karlin-Smith

Pharmaceutical manufacturers encouraged the FDA to consider including expansions and modifications of existing US drug facilities in the PreCheck program.

EU Critical Medicines Act Must Not Be ‘Watered Down,’ Industry Urges

 
• By Dave Wallace

In a strongly-worded broadside against efforts to water down the EU’s Critical Medicines Act, the off-patent industry body Medicines for Europe has criticized the “selfishness” of certain actors who prioritize lower prices at the expense of supply security.

More from Compliance

MLR Reviews: How To “Shift Left” With Agentic AI, Balance Compliance And Creativity

 
• By Vibha Ravi

Experts from UCB, Alnylam, Lantheus and Medtronic deliberate on the best use of agentic AI in the MLR review process, its human replaceability quotient and ways to balance creativity with compliance, a significant discussion amid DTC advertising and US FDA scrutiny

‘Simple Reform’ Not A Step Back From Program Alignment, US FDA’s Elizabeth Miller Argues

 
• By Derrick Gingery

Miller, FDA acting deputy associate commissioner for inspections and investigations, said veteran inspectors will retain their specialties and potentially acquire new expertise, while new recruits will begin as generalists and then be encouraged to pick a focus area.

US FDA Social Media Crackdown Looms As Industry Awaits Next Drug Ad Enforcement Wave

 
• By Sue Sutter

The first round of ad/promo violation letters largely left social media untouched despite a vow to go after “dark ads” and violative influencer claims. Industry wants more information on the new, de facto standards suggested in the initial DTC and healthcare provider promotion letters.