FDA Issues Warning Letter to API Manufacturer

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The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

On May 12, 2016, FDA issued a warning letter to Tai Heng Industry, located in Shanghai, for deviations from current good manufacturing practice. A May 2015 FDA inspection of the facility found deviations in data integrity.

Specifically, the FDA investigator found that the company had not adequately investigated out-of-specification results. The warning letter states that the company retested failed batches until they received acceptable results, but did not investigate why the batches had failed. FDA is requesting the company provide the agency with “a current risk assessment of the potential effects of the observed failures on the quality of your drugs [that includes] analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations.”

The FDA inspector also discovered that the company had failed to control its data by not preventing unauthorized access or changes to data, manipulation of data, or omission of data. The letter states, “Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards. Our investigator found that your firm routinely re-tested samples without justification, and deleted analytical data. We observed systemic data manipulation across your facility, including actions taken by multiple analysts and on multiple pieces of testing equipment. Specifically, your quality control (QC) analysts used administrator privileges and passwords to manipulate your high-performance liquid chromatography (HPLC) computer clock to alter the recorded chronology of laboratory testing events.”

The company relied on ‘mock’ data sheets, and batch production and control records were not completed immediately after activities were performed. Discrepancies between the ‘mock’ sheets and the batch production record were found. “Batch production records must be generated contemporaneously and include complete and accurate information on the production and control of each batch. The practice of using unbound, uncontrolled loose paper, in conjunction with backdating records, raises additional concerns about the integrity, authenticity, and reliability of all your data, and the quality of your API,” FDA states in the letter.


FDA is asking the company to create a management strategy detailing a global corrective action and preventive action plan (CAPA) to ensure the reliability of data and protect the quality of their product. The company is also being asked to describe enhancements to procedures, processes, methods, controls, and other systems to ensure data integrity.

Source: FDA