Serious Violations of GMP and Obstruction to an Inspection: FDA Warning Letter for a Chinese API Manufacturer

Nowadays, Warning Letters for API manufacturers from the Far East do not only list violations of current GMP regulations and data manipulation, but include more and more reports from FDA inspectors about attempts from personnel of the inspected company to trick and mislead, and to limit the on-going inspection. The News entitled "Unusual Warning Letter published by the FDA" described a particularly cheeky action against the inspectors.

Recently published, the Warning Letter issued to the Chinese API manufacturer Beijing Taiyang Pharmaceutical Industry also contains such an episode which played as follows: lookig through a window of the warehouse, the inspectors noticed a number of drums bearing the company's label. Despite the inspectors' requests, their access to this warehouse was refused without any plausible explanation. On the following day, access to the warehouse was provided to the inspectors - in the meantime, the drums had been obviously removed. The inspectors weren't informed about where those drums had been moved to.

The behaviour of one employee of the QC laboratory is consistent with this "corporate philopsophy". Indeed, he was observed trying to bring to "safety" a large pile of loose sheets. In this pile, the inspectors discovered several partially completed quality control data worksheets as well as paper notes containing sample weight values. The inspectors compared these values to those from the official QC data worksheets and identified several deficiencies.

They reviewed audit trails and found records of HPLC and GC analyses of batches whose production had been stopped 2 months before - according to a company management's statement. The corresponding chromatogrammes had been deleted, there were no logbooks available. 

Another observation in the production area - dating back batch protocols - showed that the lack of GMP understanding covered all areas of this company ("... systemic data manipulation across your facility.").

The end of the Warning Letter provides an extended list of measures to be taken to remediate the GMP deficiencies. As long as those measures are not taken, the FDA won't withdraw the Import Alert on the company's products.

To find out more details please see the Warning Letter issued to the Chinese API manufacturer Beijing Taiyang Pharmaceutical Industry Co., Ltd