The written warning to USV, dated 10 March 2017, summarizes significant violations of CGMP regulations for finished pharmaceuticals. The FDA lists the following findings:
These violations were already found at multiple company sites, e.g. in Mumbai. The FDA states that these repeated problems demonstrate that the company’s oversight and control over manufacture of drugs is inadequate. There should be an immediate and comprehensive assess to the company’s global manufacturing operations to regain conformity with FDA requirements.
Already in February 2017, Jinan Jinda, a Chinese API-manufacturer in Zangqui City, received a FDA-warning letter for significant violations of CGMP for APIs. The deviations observed by the FDA include:
In more detail the FDA writes: “Our investigator observed that your laboratory systems lacked controls to prevent your staff from altering or deleting electronic data. Analysts manipulated and deleted audit trails. You lacked adequate controls for all HPLC, gas chromatography, and ultra-violet systems. For example, an analyst deleted audit trails in your gas chromatography equipment #YQ-07-10 from September 15, 2015, through April 24, 2016, and permanently deleted audit trails from November 6 to 13, 2015. In addition, our investigator observed that your quality control manager and quality control deputy manager had full administrative rights on all of your computerized systems, which allows them to manipulate data and turn off audit trails.”
A comprehensive to-do-list is now waiting for Jinan Jinda to be fulfilled.The FDA already placed the firm on Import Alert on November 25, 2015. The question remains what has been changed since then.
FDA: Warning Letters