Sri Krishna Cited for Data Integrity Issues in FDA Warning Letter

A second FDA inspection of niche drugmaker Sri Krishna in almost 10 years has turned up a bevy of complaints regarding the company’s quality control systems and the accuracy of its data.

The agency’s first complaint in the April 1 warning letter concerns the company’s handling of data derived from compliance and specification tests. The warning letter notes that laboratory tests did not include all of the raw data generated during testing of finished products, rendering that data unreliable. Agency officials cited several examples, including a quality control analyst deleting at least two sets of data.

In addition, an analyst deleted the company’s original test method validation data and confessed to plotting to fabricate sample preparation data, the letter states. The same analyst also supposedly deleted the first set of injection data but submitted the second set in the validation and claimed that he intended to back-date the preparation data once all of the testing was complete.