After being put on an import alert by the FDA and running into problems with European regulators, Chinese API maker Jinan Jinda Pharmaceutical Chemistry announced it had hired a consultant to get its plant in order. But in a recent warning letter, the FDA said its efforts are still not enough.
The letter, issued last month, was based on an inspection in June at the plant in Zhangqiu City, Shandong Province, which found lots of problems with scant inspection on out-of-spec test results and plenty of examples of deleted test results.
The letter says that plant’s quality control laboratory disregarded multiple out-of-spec impurity results without justification and then manually reset testing equipment to exclude a peak result. Despite hiring a consultant, the FDA said that the company did not have an adequate interim plan while working to resolve its testing issues.
The FDA found other data integrity concerns, including multiple instances in which data was deleted and said that the company didn’t have adequate safeguards on its computers to prevent the problem.
The warning letter follows a recommendation in June from the European Directorate for the Quality of Medicines that Jinan Jinda's nitrofurantoin antibiotic be banned from the EU and that the plant's certificate of compliance be suspended or even “voided.” That came after Italian inspectors reported a follow-up visit in which they found raw supplies and finished products in a room in which the door had been screwed shut by employees. Inspectors "concluded there was a serious risk of data falsification" related to the ingredients in the room.