Data Integrity Violations Found at India Facility

May 22, 2019

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

FDA sent a warning letter, dated May 4, 2019, to Centurion Laboratories Private Limited after inspectors found data integrity deviations at the company’s Gujarat, India facility. During the inspection, which occurred Oct. 22–26, 2018, inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

Specifically, inspector found torn documents in trash bags that contained stability study data, analytical testing sheets, analysis calculations, and release forms. The inspector was able to remove some documents from the trash and found that the data showed out-of-specification results; however, the official results were recorded as within specification.  The inspector also found blank stability study forms that were prepared, signed, and approved by the quality unit before test data were recorded. FDA asked the company to provide a corrective actions and preventative actions plan to the agency.

According to FDA, the company also failed to ensure that only authorized personnel made changes to batch release and stability testing equipment. “For example, quality control analysts, a company executive, and your software service provider all shared a username and password for your high-performance chromatography systems. In addition, analysts were authorized full system administrator privileges. These privileges allowed modification and deletion of data files and folders. Furthermore, you lacked a procedure for controlling staff use and privileges of your computer systems,” the agency stated.

FDA recommended to the company that it perform data integrity remediation and provide a detailed investigation protocol, interviews with current and former employees, an assessment of data integrity deficiencies, and a retrospective evaluation of testing data.

In addition, according to the letter, the company failed to perform a risk assessment of drugs distributed to the United States that were manufactured on multi-use equipment that was not properly cleaned. The agency requested the company provide a plan to evaluate its cleaning procedures and validation studies, a scientific rationale for its cleaning validation strategy, a summary of updates to its cleaning validation protocol, a summary of its standard operating procedures for verification and validation of cleaning procedures, and a retrospective risk assessment.

“Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the agency stated. FDA placed the firm on Import Alert 66-40 on March 11, 2019.

Source: FDA