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Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

Posted 20 September 2018 | By Zachary Brennan 

Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals and FDA has released a third Form 483 for the company.

Following inspections in July and August, FDA issued the 483 with 11 observations, with specific issues raised about the firm’s quality unit.

“The system for managing quality to ensure confidence that the API [active pharmaceutical ingredient] will meet its intended specifications for quality and purity is not adequate in that your quality unit lacks written procedures and the authority and responsibility to ensure all critical deviations are thoroughly investigated,” the 483 released on Thursday says.

FDA also found the firm’s change control system to evaluate all changes that may affect production is not adequate.

“You do not always conduct a formal risk assessment for critical changes to evaluate the potential impact of proposed changes on the quality of intermediates or APIs,” the 483 says.

Other questions were raised about an outside laboratory Zhejiang used.

“You do not have a quality agreement with the outside laboratory you used to perform a lab scale research project requiring (prior to initiating testing and reporting results): qualification of all instruments used to conduct tests; validation of all software used with qualified instruments to conduct tests; calibration of all applicable measurement devices against traceable standards prior to use,” the 483 says.

The Form 483’s release follows the release of two other Form 483s from 2016 and 2017.
 

 

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