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4 Apr 2017

USFDA warning letter: USV’s multiple manufacturing units

In a warning letter dated 10 March 2017, FDA cites USV for issues related to sterility testing for its products and data integrity violations at the company’s Daman site where it manufactures solid-oral formulations, injectables and ophthalmic drugs.

FDA also warned USV for data integrity violations at USV’s Mumbai, India facility in 2014, citing the company for backdating records and for failing to restrict access to its quality control systems.

At the time, FDA acknowledged that USV had hired a consultant to review its data integrity practices and provided the company with a seven point list of data integrity issues that the consultant should address.

However, with the release of the new warning letter it appears that the company did not address FDA’s data integrity concerns at all its facilities.

Observations by FDA

  • “These repeated problems at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” FDA writes.
  • In this instance, FDA says USV found a total of 25 instances of deleted test results in the audit trails for two instruments used to test for sterility after FDA investigators identified six initial deleted records.
  • “Your systems allowed operators to delete files. You had no procedure to control this practice or to ensure a backup file was maintained,” FDA writes.
  • Additionally, FDA said the company didn’t restrict access to the external hard drives used to back up its microbial identification equipment, noting that any user could delete or modify files on the drive.
  • On top of the data integrity issues, FDA said it also found issues with the company’s sterility testing operations, including issues with the media plates used for microbiological testing and failure to identify bacterial and fungal specimens found during environmental monitoring.

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