Data Manipulation Continues to be a Major Issue
After a somewhat quiet month, CDER is again active in India. Their current concern is with a Company that should be familiar to each of us. And the issues in many cases are similar to those found within a Warning Letter issued in July of this year. Alexander Gaffney, RAPS Editor, has put together an excellent summary of this latest Warning Letter which I would like to share with you.
“The facilities, located in Waluj and Chikalthana, both in the state of Maharasthtra in western India, were found to be significantly deficient in their operations.
FDA said that at both locations, it found evidence of the company conducting initial “trial” testing of products before final testing. The testing is ostensibly intended to ensure that product meet specifications for purity, potency and quality. However, FDA said it found evidence that the final results were being manipulated.
“We are concerned because our investigator noticed that the “trial” injection data related to batch Redacted rendered an out-of-specification (OOS) result for the Redacted and Redacted assays,” FDA wrote. “Therefore, it appears that the batch Redacted did not pass the “trial” analysis but met specifications when the “official” sample was tested shortly thereafter.”
This “trial” injection practice was used across both facilities and multiple drug products, FDA found.
Dubious Data
Equally disturbing, FDA found evidence that the company had deleted all of its internal “trial” injection data after FDA found deficiencies at its other manufacturing facility in July 2013, implying that the company was looking to cover up other potential deficiencies.
FDA said it was concerned that there were insufficient controls to guard against data manipulation of unfavorable results—a concern that wasn’t just hypothetical, regulators added. “It appears that QC analysts attempted to mask the practice of performing sample “trial” injections by labeling them as standards rather than by the actual batch numbers or other identifying information,” FDA observed, referencing the company’s response to an FDA Form 483.
Together with the earlier Warning Letter, FDA said it was “particularly concerned about Wockhardt’s inability to implement a robust and sustainable quality system.” FDA said the “trial” injection issue was made known to the company after its previous inspection at its other facility, but that the issue went unaddressed and continued up until its most recent inspection.
Elsewhere, FDA said it also found that there were no unique log-ins for quality staff, allowing quality analysts to “access and manipulate” data without any accountability.
Both sites are now subject to an import alert until they are re-inspected and found to be compliant, FDA said.”
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