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Henan Lihua Pharmaceutical Co. Ltd. Warned for GMP violations by USFDA

Henan Lihua Pharmaceutical Co. Ltd is a Chinese Active Pharmaceutical Ingredient manufacturer which produces steroid and hormone APIs and is GMP-certified by regulators in the EU, US and China. The US Food and Drug Administration (FDA) has conducted the inspection of the company last December in which they found GMP violations and data integrity issues and therefore has given warning letter to the company.

The company was placed on import alert in March this year on account of lapses in oversight by the company's quality unit and deviations related to record keeping at the Henan province-based facility.

Following GMP violations and data integrity issues were observed during the inspection:

1) The company rubber stamped manufacturing records and access control was lacking to those forms or the stamps.
2) Numerous blank batch manufacturing records were kept in an open cabinet in the company’s manufacturing workshop as observed by the FDA investigators. Among these were multiple blank product release forms marked with a red quality assurance release stamp as 'Permitted to Leave [the] Factory,which the company justified by saying that the records were stamped in advance "for convenience"
3) 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.

Based on the above mentioned observations FDA has asked the company to perform a thorough investigation into its data records and reporting so that the company can assess the effects of these issues on the quality of its products and accordingly implement Corrective And Preventive Action Plan (CAPA).