The Chinese facility was cited for data integrity violations.
FDA sent a warning letter to Zhejiang Medicine Co. Ltd. on August 4, 2016 for violations of current good manufacturing practices (CGMP) in regards to data integrity. The violations were observed during a June 2015 inspection of the company’s Shaoxing, Zhejiang facility.
During the June 2015 inspection, investigators found that the company had failed to include complete testing data in laboratory control records. Gas chromatography (GC) analysis for residual solvents was performed on product samples, and the results were recorded in separate folders that were not part of the official quality control records. The company did not consider these results when they evaluated the quality of the API or when batch release decisions were made. FDA stated in the warning letter that the company’s response to the citation, that they performed ‘pre-trial’ sample analysis to check system suitability not for compliance, was inadequate because “FDA considers the use of an actual sample in test, prep, or equilibration runs as a means of disguising testing into compliance, a violation of CGMP.”
FDA also said in the letter that the company failed to have sufficient controls over computer systems. Specifically, the investigator found that the GC system lacked controls to prevent the manipulation, deletion, or unauthorized access of data. Analysts shared a common login ID and password. “Your use of universal administrator privileges and a single common login/password meant that actions could not be traced to specific individuals. Additionally, because the audit trail feature on the system’s software was not configured to create a file history for all activities executed by the user during analysis, your electronic data was exposed to manipulation and/or deletion without traceability,” FDA stated in the letter.
Analysts were observed pre-dating or backdating results of API quality control results and laboratory worksheets. “Worksheets were dated five days before the tests that they purported to document were actually carried out. Our investigators also observed analysts signing and dating microbiological testing laboratory worksheets five days before the test results would be available and backdating laboratory worksheets for impurities and content testing by four days,” FDA stated.
To correct these violations, FDA recommended to the company that they complete a comprehensive investigation of their quality system in regards to data integrity. The company was advised to complete an investigation of protocol and methodologies that includes a summary of all laboratory, operations, and systems. FDA advised the company to have a third party interview current and former employees to identify root causes of data inaccuracies. An assessment of data integrity deficiencies and an evaluation of analytical testing data integrity were also recommended. FDA also detailed a strategy for corrective actions and preventive actions that the company should perform.
Source: FDA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.