Regulatory Focus™ > News Articles > FDA Warns Indian API Manufacturer for Data Integrity Issues, Wild Lizard

FDA Warns Indian API Manufacturer for Data Integrity Issues, Wild Lizard

Posted 13 October 2015 | By Michael Mezher 

FDA Warns Indian API Manufacturer for Data Integrity Issues, Wild Lizard

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.

Since 2013, more than a dozen Indian API and pharmaceutical manufacturers have been cited by FDA for data integrity problems.

Data Integrity

When FDA inspected Unimark from 18-21 March 2014, they found numerous inconsistencies and violations pertaining to the company's records.

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.

The company also failed to adequately restrict access to computer systems, as FDA said Unimark did not have "unique user names, passwords, or user access levels for analysts on multiple laboratory systems," meaning any employee could potentially tamper with data generated at the facility.

FDA also found the company failed to:

  1. Document production and analytical testing activities at the time they are performed.
  2. Prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.
  3. Maintain complete data derived from all testing, and to ensure compliance with established specifications and standards.

GMP Issues

Aside from the data integrity issues, inspectors cited Unimark for failing to seal off their manufacturing building from pests and other natural elements. The inspectors note "significant gaps" in a wall where pipes enter the facility.

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.

FDA Summary                      

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.

More specifically, the agency wants to know how any data integrity issues uncovered during the inspection will impact any of Unimark's pending abbreviated new drug applications (ANDAs).

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."

Warning Letter

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