FDA Warns Indian API Manufacturer for Data Integrity Issues

The US Food and Drug Administration (FDA) on Tuesday again revealed data integrity deviations in India, this time from an inspection of Unimark Remedies' facility in Bavla, India, which produces active pharmaceutical ingredients (APIs) for at least two antibiotics – cephalosporin and carbapenem.

Data Integrity

In one instance, investigators discovered inconsistencies in batch records for a product returned to Unimark for containing "extraneous threads." In this case, the batch records for the products were signed "for periods when they were not in [Unimark's] facility," which the agency says Unimark admitted to in its response to the inspection report.

FDA also found the company failed to:

1. Prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.
2. GMP Issues

   Local fauna seem to have found their way into the gaps as well, as the investigator also "observed what appeared to be a bird's nest [and] saw bird feces on a rack on a bag … in the general raw material warehouse #2." The warning letter notes the investigator "saw a lizard" that same day in a different raw material warehouse.

   In consideration of the issues observed, FDA is asking Unimark to submit a "complete evaluation of the extent of inaccuracies in [its] reported data." The agency also wants Unimark to conduct an investigation into current and former employees to uncover the "root causes" of the company's data integrity problems.

   Lastly, FDA wants Unimark to submit a "comprehensive management strategy" to rectify the issues cited in the warning letter, and include an account of any actions the company has "taken or will take to prevent the recurrence of cGMP deviations, including breaches of data integrity."

   Source: RAPS