The U.S. drug regulator censured Wockhardt Ltd. for repeated failures at multiple sites that demonstrated “inadequate oversight", and warned of legal action if corrective measures aren’t taken.
The U.S. Food And Drug Administration (FDA) raised concerns regarding data integrity, quality controls, and manufacturing processes, in its warning letter to Wockhardt’s U.S.-based Morton Grove facility, released on March 7.
In your responses to the various actions listed above, including during multiple meetings with FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist. Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP (Current Good Manufacturing Practice) compliance.U.S. FDA Warning Letter To Wockhardt’s Morton Grove Facility
The regulator directed Wockhardt to “immediately and comprehensively assess” manufacturing operations to ensure that systems and processes conform to FDA’s requirements. The FDA warned that failure to promptly correct the violations may result in "legal action without further notice including, without limitation, seizure, and injunction."
Wockhardt will have to submit its response within 15 working days, and until the noted violations are corrected, the FDA can withhold approval of pending drug applications from the Morton Grove facility. Multiple phone calls and emails sent by BloombergQuint to Wockhardt spokesperson did not elicit any response.
The U.S. drug regulator had inspected the Illinois-based manufacturing plant from January 4 to February 5, 2016.
Here are the six key observations the FDA raised in its warning letter.
1. Failure To Investigate Unexplained Discrepancy
The U.S. FDA said Wockhardt failed to investigate unexplained discrepancies and failure to meet desired specifications.
In the same investigation, you also concluded, without performing a science-based health hazard evaluation, that such impurities do not pose health risks. You continued to distribute other batches of the same product while your OOS investigation remained open for more than five months. During the inspection, your management told our investigators that your investigation “… fell through the cracks.”
2. Data Integrity Shortfalls
The drug regulator pulled up the Mumbai-based firm for failing to include complete data from all tests in its laboratory records. The FDA cited the example of fluticasone propionate nasal spray USP, which had failed internal evaluations.
The original results were invalidated without scientific justification under the protocol and only re-test results were reported as part of batch release decisions. The original results were not reported or considered in evaluating the quality of your drugs for release.
3. Quality Control Problems
The U.S. drug regulator also said Wockhardt did not follow written procedures applicable to its quality control unit.
In multiple instances, we found that you conducted investigations into quality-related problems outside of the quality unit’s oversight and authority.
4. 'Experimental’ Manufacturing Processes
The FDA also raised concerns about the lack of control procedures to validate manufacturing processes.
When significant variability is observed in one or more stages of pharmaceutical production, it is essential that executive management support and implement effective actions to address the source(s) of the variation and provide for a continued state of control. Your firm does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.
5. Quality Control Failures
The regulator added that Wockhardt’s quality control unit failed to test in-process materials during the production process.
Contemporaneous in-process testing ensures the manufacturing process remains within its validated parameters and in a continued state of control. Our investigators documented that your manufacturing process did not subject materials to in-process testing as required.
6. Inadequate Information Technology Controls
The FDA also said that Wockhardt did not exercise appropriate controls over computers and related systems to assure that only authorized personnel could change records.
Our investigators observed that information technology (IT) staff at your facility share usernames and passwords to access your electronic storage system for (b)(4) data. Your IT staff can delete or change directories and files without identifying individuals making changes.
History Of Compliance Failure
The FDA highlighted repeat violations and deviations at multiple sites of Wockhardt since 2013. Three of Wockhardt's Indian plants - Waluj, Chikalthana, and Ankleshwar, can’t export to the U.S., while the company's subsidiary CP Pharmaceuticals got a warning letter on November 16. The Shendra facility in Aurangabad received an untitled letter on January 27, for manipulating and deleting data. So with Morton Grove warning letter, seven Wockhardt facilities are not in compliance with U.S. good manufacturing practices.
Some Respite
The Health Products Regulatory Authority of Ireland recommended the renewal of certificate for the Shendra facility, Wockhardt informed the exchanges on Tuesday.
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