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FDA Warns Chinese API Manufacturer for GMP Violations

Posted 27 June 2018 | By Michael Mezher 

FDA Warns Chinese API Manufacturer for GMP Violations

The US Food and Drug Administration (FDA) has warned Chinese active pharmaceutical ingredient (API) manufacturer Henan Lihua Pharmaceutical Co. Ltd. for good manufacturing practice (GMP) violations stemming from an inspection last December. 

According to the company's website, Henan Lihua produces steroid and hormone APIs and is GMP-certified by regulators in the EU, US and China. 

During the inspection, FDA said its investigators observed lapses in oversight by the company's quality unit and deviations related to record keeping at the Henan province-based facility. These issues resulted in the agency placing the company on import alert in March. 

GMP and Data Integrity Issues 

FDA says the company rubber stamped manufacturing records and did not control access to those forms or the stamps. 

"Our investigator observed numerous blank batch manufacturing records in an open cabinet in your manufacturing workshop office. Among these were multiple blank product release forms marked with a red quality assurance release stamp as 'Permitted to Leave [the] Factory,'" FDA writes, noting that the company said it stamped the records in advance "for convenience." 

FDA also says the company's equipment for conducting stability testing was configured to allow operators to continuously use the "preview run" function while overwriting previous runs and that the company only retained the final "preview run" for each test. 

As a result of these issues, FDA says the company must conduct a comprehensive investigation into its data records and reporting, assess the effects of any inaccuracies on the quality of its products and develop a strategy for implementing a corrective and preventative action plan (CAPA). 


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