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US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination

 
• By Bowman Cox

Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.

FDA also trains Chinese regulators and manufacturers on techniques that promote safety. At a workshop in Zhejiang province, FDA’s Daniel Geffin showed Chinese regulators how he inspects equipment used to sterilize canned foods
Zhejiang Huahai warning letter is part of US FDA/industry dialogue that includes this canned food sterilization workshop in China's Zhejiang Province • Source: US FDA

Even though Zhejiang Huahai Pharmaceuticals Co. Ltd., Linhai, China, may have been following “current industry practice,” its failure to anticipate that a manufacturing process change would introduce a carcinogenic impurity into its valsartan active pharmaceutical ingredient in 2012 was inconsistent with current good manufacturing practices, FDA told the firm in a warning letter it posted Dec. 11.

In response to FDA’s Aug. 3 inspection report, the firm on Aug. 26 implored the agency to consider that the...

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AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

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EU Ups Ante On Stockpiling For Crises

 
• By Francesca Bruce

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 
• By Francesca Bruce

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.