The FDA is demanding Wockhardt investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift the import ban it has slapped on the plant.
The agency Dec. 3 released the warning letter behind the recent ban, and it shows the FDA is concerned that quality data were manipulated and destroyed by plant employees. It has instructed the company to audit its data integrity system and determine if individuals responsible for data manipulation are still employed at the plant.
The warning letter says Wockhardt routinely failed to accurately test for drug stability, follow written procedures and secure its system of computerized data, and that its quality unit may lack authority to enforce quality standards.
The FDA says Wockhardt laboratory personnel demonstrated that they can delete electronic raw data files from the local hard drive, and quality personnel use a single, shared user ID and password to access many stand-alone systems.
During the July inspection that prompted the warning letter, FDA investigators observed repeated instances in which the drugmaker performed “trial” sample high-performance liquid chromatography analyses before performing the “official” analysis for release and stability testing, the letter states. The practice is not recognized as a validated method, the FDA says.
Wockhardt quality control analysts also attempted to mask the practice of performing sample “trial” injections by labeling them as standard, the agency adds.
To clear the agency concerns, FDA wants Wockhardt to hire a third-party auditor to evaluate the drugmaker’s data integrity.
To ensure data is not inappropriately altered or deleted, the agency wants Wockhardt to identify:
Any historical period(s) during which inaccurate data reporting occurred at its facilities;
Current and former employees to be interviewed who might have relevant information regarding any inaccurate data reporting; and
Specific managers in place when inaccurate data reporting occurred and determination of the extent of top and middle management involvement in, or awareness of, data manipulation.
Wockhardt, in an Oct. 2 response to a recent Form 483, indicated it would procure stability scheduler software to track and monitor stability plans and testing procedures.
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