USFDA Warning Letter to Chongqing Lummy Pharmaceutical Co. Ltd. China

Failure to prevent unauthorized access or changes to data and failure to provide adequate controls to prevent manipulation and omission of data.

 

Review of the audit trail for the residual solvent stability testing indicated that an analyst manipulated your computerized gas chromatography (GC) system to falsify residual solvent stability results for multiple batches API distributed to the U.S.

Set the GC personal computer (PC) clock back to make it appear as if testing had been done seven months earlier.

 

Review of the audit trails for the high performance liquid chromatography (HPLC) system indicated that, just prior to the completion of certain stability analyses for API, analysts routinely aborted the ongoing tests to prevent your HPLC system from recording some assay and impurities test data.

 

Failure to document manufacturing operations at the time they are performed.

 

Reviewed 20 executed batch manufacturing records and found that most of them contained similar or identical entries that could not be adequately explained. For example,  batch records for different batches of  API manufactured between January and February 2015, indicated that certain process steps or measurements had transpired at exactly the same time for each different batch. When investigator asked production supervisor to explain why the time stamps were identical on these records, the production supervisor stated that the full manufacturing process takes to complete, and that all batch records are kept in the production area until lots are completed. The production supervisor stated that the operators most likely did not record the actions at the time they were performed but rather completed batch records in groups.

 

Source: FDA