French regulatory agency slaps Chinese API maker with warning letter, recall

Chinese API maker slapped with warning letter, recall by French drug regulators.

French drug regulators slapped Chinese API maker Chongqing Succeway Pharmaceutical with a warning letter and issued a recall following an inspection last month.

In the notice posted on the European Medicines Agency GMP website, the French National Agency for Medicines and Health Products said inspectors found a total of 22 issues with the facility located in Chongqing, China. The latest inspection was on June 24. 

Of the total issues, one was classified as critical and three as major. The problems included manipulation, backdating and falsification of documents such as batch manufacturing record, report of starting material manufacturer audit, GC and HPLC chromatograms.

The major issue was an undeclared workshop “without any traceability of the activities undertaken” while the two major issues included undeclared storage of unidentified product and poor standards for maintaining batch manufacturing records.

The agency called for a recall of all batches of rilmenidine dihydrogen phosphate, which is used in making drugs to treat hypertension.