> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Issues in Aurobindo Inspection
- URL: https://www.fdaweb.com/cgmp-issues-in-aurobindo-inspection/
- Published: 2019-07-08T12:00:00.000Z
- Updated: 2026-09-15T01:36:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144463

A 2/4-2/9 FDA inspection at the Aurobindo Pharma drug manufacturing facility in Ranasathalam (Mandal), India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 6/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharma-limited-577033-06202019?ref=fdaweb.com) says specific deviations were: 

- failing to extend investigations to other batches that may have been associated with a specific failure or deviation;
- failing to ensure that equipment surfaces in contact with APIs do not alter the quality of the API beyond the official or other established specifications; and
- failing to report changes to methods or controls to FDA through a supplement.

The agency acknowledges that Aurobindo engaged a consultant to assist it in meeting CGMP requirements and recommends the firm engage a consultant qualified to evaluate its operations. The letter also notes that FDA cited similar CGMP observations at other facilities in the company’s network and says that “repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate.”

Aurobindo was told to schedule a regulatory meeting to discuss CGMP compliance at three of its units. It also was told to respond with a list of specific actions taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.