The US regulator criticised remediation efforts at the facility in a letter published this week, explaining that Jinan has not addressed problems identified during an inspection in May and June last year.
The agency said: “We acknowledge your commitment to hire a third-party consultant to rebuild your quality system by July 2018. However, your response is inadequate. You lack a detailed interim plan to mitigate risk while you work to resolve deficiencies and implement a robust quality system by mid-2018.”
The Food and Drug Administration (FDA) team which visited in 2016 found evidence that Jinan’s quality unit was disregarding out-of-specification (OOS) test results and failing to prevent staff from altering or deleting data.
Jinan has been banned from shipping APIs made at the facility to the US since 2015.
Europe
The US FDA warning letter comes less than a year after the Spanish Agency of medicines and medical devices (AEMPS) voiced similar concerns.
The Madrid regulator said Jinan had not addressed problems flagged by Italian Medicines Agency (IMA) inspectors who visited the site in 2015 and recommended it be banned from supplying the oral antibiotic nitrofurantoin to manufacturers in Europe.
Shortly after the IMA inspection in 2015, Jinan hired US generic API firm ChemWerth to help it address the good manufacturing practice (GMP) deficiencies.
At the time Cheng Yushui, general manager of Jinan Jinda, said the firm had signed “a five year service agreement with ChemWerth with the goal being to correct Jinda’s quality system and GMP compliance conditions.”