Ce fabricant d'API chinois sanctionné par l'US FDA...
1. Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established API specifications and standards.
Our investigator found that you failed to maintain complete data from all laboratory analyses, and that you relied on the incomplete information to determine whether your drugs met established specifications. For example:
a. Numerous data files were found in the recycle bin folder on the computer connected to gas chromatography instruments GC-4 and GC-6. Specifically, our investigator found deleted data for residual solvent testing for (b)(4) lot (b)(4) in the recycle bin. Your records show that you retested the lot without documented justification or an investigation. You retained only the final test result.
b. During the inspection our investigator requested residual solvent release test data for two of your API, (b)(4) and (b)(4). You were unable to retrieve this data.
Any data created as part of a CGMP record must be retained so that it can be evaluated by the quality unit as part of release criteria and maintained for CGMP purposes....
2. Failure to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent omission of data.Plus d'information ici.
Our investigator observed that your laboratory systems lacked controls to prevent deletion of and alterations to electronic raw data. You do not have adequate controls for seven of (b)(4) high performance liquid chromatography (HPLC) systems and one of (b)(4) gas chromatography systems. For example, the audit trail on HPLC 15 did not record the (b)(4) batch (b)(4) assay. Your records indicate that the assay was performed on March 3, 2014, but your audit trail shows no assays performed between February 28 and March 4, 2014. Moreover, your analyst demonstrated to our investigator that he could change the data, including injection time and date, without the changes being captured in the audit trail, prior to printing the results...
